Method and apparatus for a multi-use body fluid sampling device with sterility barrier release

ABSTRACT

A device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

This application is a divisional of U.S. Ser. No. 10/323,623 filed Dec.18, 2002, now U.S. Pat. No. 7,266,461 which is a continuation-in-part ofU.S. Ser. No. 10/127,395, filed Apr. 19, 2002 now U.S. Pat No.7,025,774. Said U.S. Ser. No. 10/127,395 also claiming the benefit ofU.S. Ser. No. 10/237,261, filed Sep. 5, 2002; U.S. Ser. No. 60/393,706,filed Jul. 1, 2002; U.S. Ser. No. 60/393,707, filed Jul. 1, 2002; U.S.Ser. No. 60/422,988, filed Nov. 1, 2002; U.S. Ser. No. 60/424,429, filedNov. 6, 2002; and U.S. Ser. No. 60/428,084, filed Nov. 20, 2002. Allapplications listed above are incorporated herein by reference for allpurposes.

BACKGROUND OF THE INVENTION

Lancing devices are known in the medical health-care products industryfor piercing the skin to produce blood for analysis. Typically, a dropof blood for this type of analysis is obtained by making a smallincision in the fingertip, creating a small wound, which generates asmall blood droplet on the surface of the skin.

Early methods of lancing included piercing or slicing the skin with aneedle or razor. Current methods utilize lancing devices that contain amultitude of spring, cam and mass actuators to drive the lancet. Theseinclude cantilever springs, diaphragms, coil springs, as well as gravityplumbs used to drive the lancet. The device may be held against the skinand mechanically triggered to ballistically launch the lancet.Unfortunately, the pain associated with each lancing event using knowntechnology discourages patients from testing. In addition to vibratorystimulation of the skin as the driver impacts the end of a launcherstop, known spring based devices have the possibility of firing lancetsthat harmonically oscillate against the patient tissue, causing multiplestrikes due to recoil. This recoil and multiple strikes of the lancet isone major impediment to patient compliance with a structured glucosemonitoring regime.

Another impediment to patient compliance is the lack of spontaneousblood flow generated by known lancing technology. In addition to thepain as discussed above, a patient may need more than one lancing eventto obtain a blood sample since spontaneous blood generation isunreliable using known lancing technology. Thus the pain is multipliedby the number of attempts required by a patient to successfully generatespontaneous blood flow. Different skin thickness may yield differentresults in terms of pain perception, blood yield and success rate ofobtaining blood between different users of the lancing device. Knowndevices poorly account for these skin thickness variations.

A still further impediment to improved compliance with glucosemonitoring are the many steps and inconvenience associated with eachlancing event. Many diabetic patients that are insulin dependent mayneed to self-test for blood glucose levels five to six times daily. Thelarge number of steps required in traditional methods of glucosetesting, ranging from lancing, to milking of blood, applying blood to atest strip, and getting the measurements from the test strip,discourages many diabetic patients from testing their blood glucoselevels as often as recommended. Older patients and those withdeteriorating motor skills encounter difficulty loading lancets intolauncher devices, transferring blood onto a test strip, or insertingthin test strips into slots on glucose measurement meters. Additionally,the wound channel left on the patient by known systems may also be of asize that discourages those who are active with their hands or who areworried about healing of those wound channels from testing their glucoselevels.

SUMMARY OF THE INVENTION

The present invention provides solutions for at least some of thedrawbacks discussed above. Specifically, some embodiments of the presentinvention provide a multiple lancet solution to measuring analyte levelsin the body. The invention may use a high density design. At least someof these and other objectives described herein will be met byembodiments of the present invention.

These and other objects of the present invention are achieved in adevice for use with a gripper. A cartridge is provided that defines aplurality of cavities. A plurality of penetrating members are at leastpartially contained in the cavities of the cartridge. The penetratingmembers are slidably movable to extend outward from the cartridge topenetrate tissue. Each cavity has a longitudinal opening that providesaccess to an elongate portion of the penetrating member. A sterilitybarrier is coupled to the cartridge. The sterility barrier covers aplurality of the longitudinal openings. The sterility barrier isconfigured to be moved so that the elongate portion is accessed by thegripper without touching the barrier.

In another embodiment of the present invention, a device for use inpenetrating tissue to obtain a body fluid sample includes a cartridgeand a plurality of penetrating members slidably coupled to thecartridge. Each penetrating member has a distal end sufficiently sharpto pierce tissue. Each penetrating member is moveable relative to theother ones so that the distal end of the respective penetrating memberis movable to penetrate tissue. Each penetrating member is a bare lancetand does not penetrate an outer sterility barrier during actuation.

In another embodiment of the present invention, a device is providedwith a cartridge that has a plurality of cavities. A plurality ofpenetrating members are at least partially contained in the cavities.The penetrating members are slidably movable to extend outward fromlateral openings on the cartridge to penetrate tissue. A sterilitybarrier is coupled to the cartridge. The sterility barrier covers aplurality of the lateral openings and is configured to be moved so thata penetrating member exits the lateral opening without contacting thebarrier.

In another embodiment of the present invention, a device is providedwith means for housing a plurality of penetrating members in a radialconfiguration. The penetrating members are individually couplable to adriver.

In another embodiment of the present invention, a lancing systemincludes a cartridge that defines a plurality of cavities. A pluralityof penetrating members are at least partially contained in the cavities.The penetrating members are slidably movable to extend outward fromlateral openings on the cartridge to penetrate tissue. A sterilitybarrier is coupled to the cartridge. The sterility barrier covers atleast one of the lateral openings and is configured to be moved so thata penetrating member exiting from the lateral opening during actuationwill not contact the barrier. An electrically powered drive forcegenerator is operatively coupled to an active one of the penetratingmembers to drive the active penetrating member into a tissue site.

In another embodiment of the present invention, a lancing system has acartridge that defines a plurality of cavities. A plurality ofpenetrating members are at least partially contained in the cavities.The penetrating members are slidably movable to extend outward fromlateral openings on the cartridge to penetrate tissue. A sterilitybarrier is coupled to the cartridge. The sterility barrier covers atleast one of the lateral openings and is configured to be moved so thata penetrating member exiting the lateral opening during actuation willnot contact the barrier. A feedback loop controls trajectory of eachpenetrating member extending outward from the cartridge duringactuation.

In another embodiment of the present invention, a lancing systemincludes a single cartridge with a plurality of cavities. A plurality ofpenetrating members are at least partially contained in the cavities.The penetrating members are slidably movable to extend outward from thecartridge to penetrate tissue. Each cavity has a longitudinal openingthat provides access to an elongate portion of the penetrating member. Asterility barrier is coupled to the cartridge and covers a plurality ofthe longitudinal openings. A punch is movable to penetrate the sterilitybarrier and release one of the penetrating members from a sterileenvironment created by the sterility barrier.

In another embodiment of the present invention, a lancing system has asingle cartridge with a plurality of cavities. A plurality ofpenetrating members are at least partially contained in the cavities.The penetrating members are slidably movable to extend outward fromlateral openings on the cartridge to penetrate tissue. A sterilitybarrier is coupled to the cartridge and covers a plurality of thelateral openings. A punch is movable to penetrate the sterility barrier,and pushes the sterility barrier into a position so that the penetratingmember are actuated without contacting the sterility barrier.

In another embodiment of the present invention, a device includes asingle cartridge. A plurality of penetrating members are coupled to thesingle cartridge and are couplable to a driver. A plurality of openingson the cartridge are configured to position the cartridge to align anunused penetrating member with the driver. An actuator is configured toengage the openings and actuate the cartridge to move the unusedpenetrating member into alignment with the driver.

In another embodiment of the present invention, a lancing systemincludes a driver. A cartridge has a plurality of bare lancets coupledto the cartridge. A lancet gripper is coupled to the driver. The gripperhas a slot for receiving at least one of the bare lancets. The slotcreates a frictional grip with the bare lancets.

In another embodiment of the present invention, a lancing systemincludes a lancet driver. A plurality of lancets are in a disc-shapedhousing. A lancet gripper is included. A lancet release device isprovided for releasing the lancet for a sterile environment prior touse. An actuator is configured to move the disc-shaped housing relativeto the lancet gripper to bring one of the lancets into contact with thelancet gripper.

In another embodiment of the present invention, a lancing systemincludes a lancet driver. A cartridge housing is provided with theplurality of lancets. A lancet gripper is coupled to the lancet driver.A lancet release device releases one of the lancets from a sterileenvironment prior to use. The cartridge is movable relative to thelancet driver to engage and disengage one of the lancets from the lancetgripper.

In another embodiment of the present invention, a lancing system isprovided for use with a driver and includes means for releasing apenetrating member from a sterile enclosure on a cartridge. Thecartridge has a plurality of sterile enclosures and a plurality ofpenetrating members. Means are included for aligning and operativelycoupling the penetrating member to the driver.

In another embodiment of the present invention, a method is provided forloading a cartridge that has a plurality of penetrating members into ahousing of a lancing apparatus. Each penetrating member is released froma sterilized environment on the cartridge. The penetrating member istransported within the housing towards a launch position. The lancet isloaded to be operatively coupled to a penetrating member driver in theapparatus.

In another embodiment of the present invention, a method provides acartridge that has a plurality of individually sealed cavities, eachcontaining a penetrating member. A punch plate is lowered to release anunused penetrating member from one of the sealed cavities. The cartridgeis rotated to align the unused penetrating member with a gripper. Africtional engagement is created with the penetrating member byinserting the penetrating member into a receiving slot on the gripper.

In another embodiment of the present invention, a method provides acartridge that has a plurality of cavities, each containing apenetrating member. Each member is held by a coupling to the cartridge.A penetrating member is engaged with a gripper. A first force generatoris used to move the gripper in a manner sufficient to release thepenetrating member from the coupling to the cartridge. A second forcegenerator is used to move the gripper in a manner sufficient to drivethe penetrating member into tissue.

In another embodiment of the present invention, a method provides acartridge that has a plurality of cavities, each containing apenetrating member. Each member is held by a coupling to the cartridge.A punch device and a penetrating member gripper are provided. Relativemotion between the cartridge and the gripper is created and thecartridge is separated from the gripper. Relative motion between thecartridge and the gripper is created and the gripper is aligned over anunused penetrating member in the cartridge. Relative motion between thecartridge and the gripper is created and the gripper is engaged with theunused penetrating member.

In another embodiment of the present invention, a method provides alancet driver. A visual display is installed on the lancet driver. Thedisplay is coupled to a processor, relays lancet information selectedfrom, lancing performance or lancing setting.

In another embodiment of the present invention, a method provides acartridge that has a plurality of cavities. A plurality of penetratingmembers are inserted and are at least partially contained in thecavities of the cartridge. The penetrating members are slidably movableto extend outward from lateral openings on the cartridge to penetratetissue. A sterility barrier is added to the cartridge and covers aplurality of the lateral openings.

In another embodiment of the present invention, a manufacturing methodprovides a cartridge that has a plurality of cavities for holdingpenetrating members. The cartridge is sterilized while each of thecavities is in a sealed condition. The cartridge contains a plurality ofpenetrating members. A planar sheet of sterility barrier material isused to cover a plurality of the cavities to create a sterileenvironment inside each of the cavities.

In another embodiment of the present invention, a method provides acartridge that has a plurality of bare lancets. At least a portion of asterility barrier is moved such that an active one of the bare lancetsexits the cartridge to penetrate tissue without contacting the sterilitybarrier. The active one of the bare lancets is retracted back into thecartridge after penetrating tissue.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating a system, according to anembodiment for use in piercing skin to obtain a blood sample;

FIG. 2 is a plan view of a portion of a replaceable penetrating membercartridge forming part of the system;

FIG. 3 is a cross-sectional end view on 3-3 in FIG. 2;

FIG. 4 is a cross-sectional end view on 4-4 in FIG. 2;

FIG. 5 is a perspective view of an apparatus forming part of the systemand used for manipulating components of the cartridge, illustratingpivoting of a penetrating member accelerator in a downward direction;

FIG. 6A is a view similar to FIG. 5, illustrating how the cartridge isrotated or advanced;

FIG. 6B is a cross-sectional side view illustrating how the penetratingmember accelerator allows for the cartridge to be advanced;

FIGS. 7A and 7B are views similar to FIGS. 6A and 6B, respectively,illustrating pivoting of the penetrating member accelerator in anopposite direction to engage with a select one of the penetratingmembers in the cartridge;

FIGS. 8A and 8B are views similar to FIGS. 7A and 7B, respectively,illustrating how the penetrating member accelerator moves the selectedpenetrating member to pierce skin;

FIGS. 9A and 9B are views similar to FIGS. 8A and 8B, respectively,illustrating how the penetrating member accelerator returns thepenetrating member to its original position;

FIG. 10 is a block diagram illustrating functional components of theapparatus; and

FIG. 11 is an end view illustrating a cartridge according to an optionalembodiment that allows for better adhesion of sterilization barriers.

FIG. 12 is a cross-sectional view of an embodiment having features ofthe invention.

FIG. 13 is a cross-sectional view of an embodiment having features ofthe invention in operation.

FIG. 14 is a cross-sectional view illustrating a low-friction coatingapplied to one penetrating member contact surface.

FIG. 15 is a cross-sectional view illustrating a coating applied to onepenetrating member contact surface which increases friction and improvesthe microscopic contact area between the penetrating member and thepenetrating member contact surface.

FIG. 16 illustrates a portion of a penetrating member cartridge havingan annular configuration with a plurality of radially orientedpenetrating member slots and a distal edge of a drive member disposed inone of the penetrating member slots.

FIG. 17 is an elevational view in partial longitudinal section of acoated penetrating member in contact with a coated penetrating membercontact surface.

FIG. 18 illustrates an embodiment of a lancing device having features ofthe invention.

FIG. 19 is a perspective view of a portion of a penetrating membercartridge base plate having a plurality of penetrating member slots anddrive member guide slots disposed radially inward of and aligned withthe penetrating member slots.

FIGS. 20-22 illustrate a penetrating member cartridge in section, adrive member, a penetrating member and the tip of a patient's fingerduring three sequential phases of a lancing cycle.

FIG. 23 illustrates an embodiment of a penetrating member cartridgehaving features of the invention.

FIG. 24 is an exploded view of a portion of the penetrating membercartridge of FIG. 12.

FIGS. 25 and 26 illustrate a multiple layer sterility barrier disposedover a penetrating member slot being penetrated by the distal end of apenetrating member during a lancing cycle.

FIGS. 27 and 28 illustrate an embodiment of a drive member coupled to adriver wherein the drive member includes a cutting member having asharpened edge which is configured to cut through a sterility barrier ofa penetrating member slot during a lancing cycle in order for the drivemember to make contact with the penetrating member.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot inlongitudinal section having a ramped portion disposed at a distal end ofthe penetrating member slot and a drive member with a cutting edge at adistal end thereof for cutting through a sterility barrier during alancing cycle.

FIGS. 31-34 illustrate drive member slots in a penetrating membercartridge wherein at least a portion of the drive member slots have atapered opening which is larger in transverse dimension at the top ofthe drive member slot than at the bottom of the drive member slot.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridgeand penetrating member drive member wherein the penetrating member drivemember has a contoured jaws configured to grip a penetrating membershaft.

FIGS. 38 and 39 show a portion of a lancing device having a lid that canbe opened to expose a penetrating member cartridge cavity for removal ofa used penetrating member cartridge and insertion of a new penetratingmember cartridge.

FIGS. 40 and 41 illustrate a penetrating member cartridge that haspenetrating member slots on both sides.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge having a plurality of penetrating member slots formed from acorrugated surface of the penetrating member cartridge.

FIGS. 45-48 illustrate embodiments of a penetrating member and drivemember wherein the penetrating member has a slotted shaft and the drivemember has a protuberance configured to mate with the slot in thepenetrating member shaft.

FIG. 49 is a perspective view of a cartridge according to the presentinvention.

FIGS. 50 and 51 show close-ups of outer peripheries various cartridges.

FIG. 52 is a perspective view of an underside of a cartridge.

FIG. 53A shows a top down view of a cartridge and the punch and pusherdevices.

FIG. 53B is a perspective view of one embodiment of a punch plate.

FIGS. 54A-54G show a sequence of motion for the punch plate, thecartridge, and the cartridge pusher.

FIGS. 55A-55B show cross-sections of the system according to the presentinvention.

FIG. 56A shows a perspective view of the system according to the presentinvention.

FIGS. 56B-56D are cut-away views showing mechanisms within the presentinvention.

FIGS. 57-65B show optional embodiments according to the presentinvention.

FIGS. 66-68 shows a still further embodiment of a cartridge according tothe present invention.

FIGS. 69A-69L show the sequence of motions associated with an optionalembodiment of a cartridge according to the present invention.

FIGS. 70-72 show views of a sample modules used with still furtherembodiments of a cartridge according to the present invention.

FIG. 73 shows a cartridge with a sterility barrier and a sensor layer.

FIGS. 74-78 show still further embodiments of analyte sensors coupled toa cartridge.

FIGS. 79-84 show optional configurations for a cartridge for use withthe present invention.

FIG. 85 shows a see-through view of one embodiment of a system accordingto the present invention.

FIG. 86 is a schematic of an optional embodiment of a system accordingto the present invention.

FIGS. 87A-87B show still further embodiments of cartridges according tothe present invention.

FIG. 88 shows a cartridge having an array of analyte sensors.

FIGS. 89-90 show embodiments of illumination systems for use with thepresent invention.

FIGS. 91-92 show a cross-section of further embodiments of theillumination system.

FIG. 93 shows a cross-section of a system similar to that of FIG. 89.

FIG. 94 shows a cross-section of a system similar to that of FIG. 90.

FIGS. 95-96 show further views of a system similar to that of FIG. 89.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The present invention provides a multiple sensor solution for body fluidsampling. Specifically, some embodiments of the present inventionprovides a multiple sensor and multiple lancet solution to measuringanalyte levels in the body. The invention may use a high density design.It may use lancets of smaller size than known lancets. The device may beused for multiple lancing events without having to remove a disposablefrom the device. The invention may provide improved sensingcapabilities. At least some of these and other objectives describedherein will be met by embodiments of the present invention.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It must be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a chamber” may includemultiple chambers, and the like. References cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for analyzing ablood sample, this means that the analysis feature may or may not bepresent, and, thus, the description includes structures wherein a devicepossesses the analysis feature and structures wherein the analysisfeature is not present.

“Analyte sensor” refers to any use, singly or in combination, ofchemical test reagents and methods, electrical test circuits andmethods, physical test components and methods, optical test componentsand methods, and biological test reagents and methods to yieldinformation about a blood sample. Such methods are well known in the artand may be based on teachings of, e.g. Tietz Textbook of ClinicalChemistry, 3d Ed., Sec. V, pp. 776-78 (Burtis & Ashwood, Eds., W. B.Saunders Company, Philadelphia, 1999); U.S. Pat. No. 5,997,817 toChrismore et al. (Dec. 7, 1999); U.S. Pat. No. 5,059,394 to Phillips etal. (Oct. 22, 1991); U.S. Pat. No. 5,001,054 to Wagner et al. (Mar. 19,1991); and U.S. Pat. No. 4,392,933 to Nakamura et al. (Jul. 12, 1983),the teachings of which are hereby incorporated by reference, as well asothers. Analyte sensor may include sensors in the sample test chamberthat test electrochemical properties of the blood, or they may includeoptical means for sensing optical properties of the blood (e.g. oxygensaturation level), or they may include biochemical reagents (e.g.antibodies) to sense properties (e.g. presence of antigens) of theblood. Said analyte sensor may be present at, e.g., a “test site” or an“analytical site.” The analyte sensor may comprise biosensing or reagentmaterial that will react with an analyte in the blood (e.g. glucose) sothat an appropriate signal correlating with the presence of the analyteis generated and can be read by the reader apparatus. Analyte sensor are“associated with” a chamber or other structure when the analyte sensorparticipates in the function of providing an appropriate signal aboutthe blood sample to the reader device. Analyte sensor may also includenanowire sensors as described herein. Analyte sensor may usepotentiometric, coulometric, or other method useful for detection ofanalyte levels.

FIGS. 1-11 of the accompanying drawings illustrates one embodiment of asystem 10 for piercing skin to obtain a blood sample. The system 10 mayinclude a replaceable cartridge 12 and an apparatus 14 for removablyreceiving the cartridge 12 and for manipulating components of thecartridge 12.

Referring jointly to FIGS. 1 and 2, the cartridge 12 may include aplurality of penetrating members 18. The cartridge 12 may be in the formof a circular disc and has an outer circular surface 20 and an openingforming an inner circular surface 22. A plurality of grooves 24 areformed in a planar surface 26 of the cartridge 12. Each groove 24 iselongated and extends radially out from a center point of the cartridge12. Each groove 24 is formed through the outer circular surface 20.Although not shown, it should be understood that the grooves 24 areformed over the entire circumference of the planar surface 26. As shownin FIGS. 3 and 4, each groove 24 is relatively narrow closer to thecenter point of the cartridge 12 and slightly wider further from thecenter point. These grooves 24 may be molded into the cartridge 12,machined into the cartridge, or formed using other methods useful in themanufacture of medical devices.

In the present embodiment, each penetrating member 18 has an elongatedbody 26 and a sharpened distal end 27 having a sharp tip 30. Thepenetrating member 18 may have a circular in cross-section with adiameter in this embodiment of about 0.315 mm. All outer surfaces of thepenetrating member 18 may have the same coefficient of friction. Thepenetrating member may be, but is not necessarily, a bare lancet. Thelancet is “bare”, in the sense that no raised formations or molded partsare formed thereon that are complementarily engageable with anotherstructure. Traditional lancets include large plastic molded parts thatare used to facilitate engagement. Unfortunately, such attachments addsize and cost. In the most basic sense, a bare lancet or barepenetrating member is an elongate wire having sharpened end. If it is ofsufficiently small diameter, the tip may be penetrating without havingto be sharpened. A bare lancet may be bent and still be considered abare lancet. The bare lancet in one embodiment may be made of onematerial.

In the present embodiment, each penetrating member 18 is located in arespective one of the grooves 24. The penetrating members 18 have theirsharpened distal ends 27 pointed radially out from the center point ofthe cartridge 12. A proximal end of each penetrating member 15 mayengage in an interference fit with opposing sides of a respective groove24 as shown in FIG. 3. Other embodiments of the cartridge 12 may not usesuch an interference fit. For example, they may use a fracturableadhesive to releasably secure the penetrating member 18 to the cartridge12. As shown in FIG. 4, more distal portions of the penetrating member18 are not engaged with the opposing sides of the groove 24 due to thelarger spacing between the sides.

The cartridge 12 may further include a sterilization barrier 28 attachedto the upper surface 26. The sterilization barrier 28 is located overthe penetrating members 18 and serves to insulate the penetratingmembers 18 from external contaminants. The sterilization barrier 28 ismade of a material that can easily be broken when an edge of a deviceapplies a force thereto. The sterilization barrier 28 alone or incombination with other barriers may be used to create a sterileenvironment about at least the tip of the penetrating member prior tolancing or actuation. The sterilization barrier 28 may be made of avariety of materials such as but not limited to metallic foil, aluminumfoil, paper, polymeric material, or laminates combining any of theabove. Other details of the sterilization barrier are detailed herein.

In the present embodiment, the apparatus 14 may include a housing 30, aninitiator button 32, a penetrating member movement subassembly 34, acartridge advance subassembly 36, batteries 38, a capacitor 40, amicroprocessor controller 42, and switches 44. The housing 30 may have alower portion 46 and a lid 48. The lid 48 is secured to the lowerportion 46 with a hinge 50. The lower portion 46 may have a recess 52. Acircular opening 54 in the lower portion 46 defines an outer boundary ofthe recess 52 and a level platform 56 of the lower portion 46 defines abase of the recess 52.

In use, the lid 48 of the present embodiment is pivoted into a positionas shown in FIG. 1. The cartridge 12 is flipped over and positioned inthe recess 52. The planar surface 26 rests against the level platform 56and the circular opening 54 contacts the outer circular surface 20 toprevent movement of the cartridge 12 in a plane thereof. The lid 48 isthen pivoted in a direction 60 and closes the cartridge 12.

Referring to the embodiment shown in FIG. 5, the penetrating membermovement subassembly 34 includes a lever 62, a penetrating memberaccelerator 64, a linear actuator 66, and a spring 68. Other suitableactuators including but not limited to rotary actuators are described incommonly assigned, copending U.S. patent application Ser. No. 10/127,395filed Apr. 19, 2002. The lever 62 may be pivotably secured to the lowerportion 46. The button 32 is located in an accessible position externalof the lower portion 46 and is connected by a shaft 70 through the lowerportion 46 to one end of the lever 62. The penetrating memberaccelerator 64 is mounted to an opposing end of the lever 62. A userdepresses the button 32 in an upward direction 66 so that the shaft 70pivots the end of the lever 62 to which it is connected in an upwarddirection. The opposing end of the lever pivots in a downward direction66. The spring 46 is positioned between the button 32 and the base 40and compresses when the button 32 is depressed to create a force thattends to move the button 32 down and pivot the penetrating memberaccelerator upward in a direction opposite to the direction 64.

Referring to FIGS. 6A and 6B in this particular embodiment, the movementof the button into the position shown in FIG. 5 also causes contactbetween a terminal 74 on the shaft 20 with a terminal 70 secured to thelower portion 46. Contact between the terminals 74 and 76 indicates thatthe button 32 has been fully depressed. With the button 32 depressed,the cartridge 12 can be rotated without interference by the penetratingmember actuator 64. To this effect, the cartridge advancer subsystem 36includes a pinion gear 80 and a stepper motor 82. The stepper motor 82is secured to the lower portion 46. The pinion gear 80 is secured to thestepper motor 82 and is rotated by the stepper motor 82. Teeth on thepinion gear 80 engage with teeth on the inner circular surface 22 of thecartridge 12. Rotation of the pinion gear 80 causes rotation of thecartridge 12 about the center point thereof. Each time that theterminals 74 and 76 make contact, the stepper motor 82 is operated torotate the cartridge 12 through a discrete angle equal to an angularspacing from a centerline of one of the penetrating members 18 to acenterline of an adjacent penetrating member. A select penetratingmember 18 is so moved over the penetrating member accelerator 64, asshown in FIG. 6B. Subsequent depressions of the button 32 will causerotation of subsequent adjacent penetrating members 18 into a positionover the penetrating member accelerator 64.

The user then releases pressure from the button, as shown in FIG. 7A.The force created by the spring 68 or other resilient member moves thebutton 32 in a downward direction 76. The shaft 70 is pivotably securedto the lever 62 so that the shaft 70 moves the end of the lever 62 towhich it is connected down. The opposite end of the lever 62 pivots thepenetrating member accelerator 64 upward in a direction 80. As shown inFIG. 7B, an edge 82 of the penetrating member accelerator 64 breaksthrough a portion of the sterilization barrier 28 and comes in tophysical contact with a lower side surface of the penetrating member 18.

Referring to FIG. 8A, the linear actuator 66 includes separate advancingcoils 86A and retracting coils 86B, and a magnetizable slug 90 withinthe coils 86A and 86B. The coils 86A and 86B are secured to the lowerportion of 46, and the slug 90 can move within the coils 86A and 88B.Once the penetrating member accelerator 64 is located in the positionshown in FIGS. 7A and 7B, electric current is provided to the advancingcoils 86 only. The current in the advancing coils 86 creates a force ina direction 88 on the slug 90 according to conventional principlesrelating to electromagnetics.

A bearing 91 is secured to the lever and the penetrating memberaccelerator 64 has a slot 92 over the bearing 91. The slot 92 allows forthe movement of the penetrating member accelerator 64 in the direction88 relative to the lever 62, so that the force created on the slug movesthe penetrating member accelerator 64 in the direction 88.

The spring 68 is not entirely relaxed, so that the spring 68, throughthe lever 62, biases the penetrating member accelerator 64 against thelower side surface of the penetrating member 18 with a force F1. Thepenetrating member 18 rests against a base 88 of the cartridge 12. Anequal and opposing force F2 is created by the base 88 on an upper sidesurface of the penetrating member 18.

The edge 82 of the penetrating member accelerator 64 has a much highercoefficient of friction than the base 88 of the cartridge 12. The highercoefficient of friction of the edge contributes to a relatively highfriction force F3 on the lower side surface of the penetrating member18. The relatively low coefficient of friction of the base 88 creates arelatively small friction force F4 on the upper side surface of thepenetrating member 18. A difference between the force F3 and F4 is aresultant force that accelerates the penetrating member in the direction88 relative to the cartridge 12. The penetrating member is moved out ofthe interference fit illustrated in FIG. 3. The bare penetrating member18 is moved without the need for any engagement formations on thepenetrating member. Current devices, in contrast, often make use aplastic body molded onto each penetrating member to aid in manipulatingthe penetrating members. Movement of the penetrating member 18 moves thesharpened end thereof through an opening 90 in a side of the lowerportion 46. The sharp end 30 of the penetrating member 18 is therebymoved from a retracted and safe position within the lower portion 46into a position wherein it extends out of the opening 90. Accelerated,high-speed movement of the penetrating member is used so that the sharptip 30 penetrates skin of a person. A blood sample can then be takenfrom the person, typically for diabetic analysis.

Reference is now made to FIGS. 9A and 9B. After the penetrating memberis accelerated (for example, but not limitation, less than 0.25 secondsthereafter), the current to the accelerating coils 86A is turned off andthe current is provided to the retracting coils 86B. The slug 90 movesin an opposite direction 92 together with the penetrating memberaccelerator 64. The penetrating member accelerator 64 then returns theused penetrating member into its original position, i.e., the same asshown in FIG. 7B.

Subsequent depression of the button as shown in FIG. 5 will then causeone repetition of the process described, but with an adjacent sterilepenetrating member. Subsequent sterile penetrating members can so beused until all the penetrating members have been used, i.e., after onecomplete revolution of the cartridge 12. In this embodiment, a secondrevolution of the cartridge 12 is disallowed to prevent the use ofpenetrating members that have been used in a previous revolution andhave become contaminated. The only way in which the user can continue touse the apparatus 14 is by opening the lid 48 as shown in FIG. 1,removing the used cartridge 12, and replacing the used cartridge withanother cartridge. A sensor (not shown) detects whenever a cartridge isremoved and replaced with another cartridge. Such a sensor may be but isnot limited to an optical sensor, an electrical contact sensor, a barcode reader, or the like.

FIG. 10 illustrates the manner in which the electrical components may befunctionally interconnected for the present embodiment. The battery 38provides power to the capacitor 40 and the controller 42. The terminal76 is connected to the controller 42 so that the controller recognizeswhen the button 32 is depressed. The capacitor to provide power(electric potential and current) individually through the switches (suchas field-effect transistors) to the advancing coils 86A, retractingcoils 86B and the stepper motor 82. The switches 44A, B, and C are allunder the control of the controller 42. A memory 100 is connected to thecontroller. A set of instructions is stored in the memory 100 and isreadable by the controller 42. Further functioning of the controller 42in combination with the terminal 76 and the switches 44A, B, and Cshould be evident from the foregoing description.

FIG. 11 illustrates a configuration for another embodiment of acartridge having penetrating members. The cartridge 112 has a corrugatedconfiguration and a plurality of penetrating members 118 in grooves 124formed in opposing sides of the cartridge 112. Sterilization barriers126 and 128 are attached over the penetrating members 118 at the top andthe penetrating members 118 at the bottom, respectively. Such anarrangement provides large surfaces for attachment of the sterilizationbarriers 126 and 128. All the penetrating members 118 on the one sideare used first, whereafter the cartridge 112 is turned over and thepenetrating members 118 on the other side are used. Additional aspectsof such a cartridge are also discussed in FIGS. 42-44.

Referring now to FIGS. 12-13, a friction based method of coupling withand driving bare lancets or bare penetrating members will be describedin further detail. Any embodiment of the present invention disclosedherein may be adapted to use these methods. As seen in FIG. 12, surface201 is physically in contact with penetrating member 202. Surface 203 isalso physically in contact with penetrating member 202. In the presentembodiment of the invention, surface 201 is stainless steel, penetratingmember 202 is stainless steel, and surface 203 ispolytetrafluoroethylene-coated stainless steel.

FIG. 13 illustrates one embodiment of the friction based coupling inuse. Normal force 206 may be applied vertically to surface 201, pressingit against penetrating member 202. Penetrating member 202 is therebypressed against surface 203. Normal force 206 is transmitted throughsurface 201 and penetrating member 202 to also act between penetratingmember 202 and surface 203. Surface 203 is held rigid or stationary withrespect to a target of the lancet. Using the classical static frictionmodel, the maximum frictional force between surface 201 and penetratingmember 202 is equal to the friction coefficient between surface 201 andpenetrating member 202 multiplied by the normal force between surface201 and penetrating member 202. In this embodiment, the maximumfrictional force between surface 203 and penetrating member 202 is equalto the coefficient of friction between the surface 203 and thepenetrating member 202 multiplied by the normal force between thesurface 203 and the penetrating member 202. Because friction coefficientbetween surface 203 and penetrating member 202 is less than frictioncoefficient between surface 201 and penetrating member 202, theinterface between surface 201 and penetrating member 202 can develop ahigher maximum static friction force than can the interface betweensurface 203 and penetrating member 202.

Driving force as indicated by arrow 207 is applied to surface 201perpendicular to normal force 206. The sum of the forces actinghorizontally on surface 201 is the sum of driving force 207 and thefriction force developed at the interface of surface 201 and penetratingmember 202, which acts in opposition to driving force 207. Since thecoefficient of friction between surface 203 and penetrating member 202is less than the coefficient of friction between surface 201 andpenetrating member 202, penetrating member 202 and surface 201 willremain stationary with respect to each other and can be considered tobehave as one piece when driving force 207 just exceeds the maximumfrictional force that can be supported by the interface between surface203 and penetrating member 202. Surface 201 and penetrating member 202can be considered one piece because the coefficient of friction betweensurface 201 and penetrating member 202 is high enough to preventrelative motion between the two.

In one embodiment, the coefficient of friction between surface 201 andpenetrating member 202 is approximately 0.8 corresponding to thecoefficient of friction between two surfaces of stainless steel, whilethe coefficient of friction between surface 203 and penetrating member202 is approximately 0.04, corresponding to the coefficient of frictionbetween a surface of stainless steel and one of polytetrafluoroethylene.Normal force 206 has a value of 202 Newtons. Using these values, themaximum frictional force that the interface between surface 201 andpenetrating member 202 can support is 1.6 Newtons, while the maximumfrictional force that the interface between surface 203 and penetratingmember 202 can support is 0.08 Newtons. If driving force 207 exceeds0.08 Newtons, surface 201 and penetrating member 202 will begin toaccelerate together with respect to surface 203. Likewise, if drivingforce 207 exceeds 1.6 Newtons and penetrating member 202 encounters arigid barrier, surface 201 would move relative to penetrating member202.

Another condition, for example, for surface 201 to move relative topenetrating member 202 would be in the case of extreme acceleration. Inan embodiment, penetrating member 202 has a mass of 8.24×10−6 kg. Anacceleration of 194,174 m/s2 of penetrating member 202 would thereforebe required to exceed the frictional force between penetrating member202 and surface 201, corresponding to approximately 19,800 g's. Withoutbeing bound to any particular embodiment or theory of operation, othermethods of applying friction base coupling may also be used. Forexample, the penetrating member 202 may be engaged by a coupler using ainterference fit to create the frictional engagement with the member.

FIG. 14 illustrates a polytetrafluoroethylene coating on stainless steelsurface 203 in detail. It should be understood that the surface 203 maybe coated with other materials such as but not limited to Telfon®,silicon, polymer or glass. The coating may cover all of the penetratingmember, only the proximal portions, only the distal portions, only thetip, only some other portion, or some combination of some or all of theabove. FIG. 15 illustrates a doping of lead applied to surface 201,which conforms to penetrating member 202 microscopically when pressedagainst it. Both of these embodiments and other coated embodiments of apenetrating member may be used with the actuation methods describedherein.

The shapes and configurations of surface 201 and surface 102 could besome form other than shown in FIGS. 12-15. For example, surface 201could be the surface of a wheel, which when rotated causes penetratingmember 202 to advance or retract relative to surface 203. Surface 201could be coated with another conformable material besides lead, such asa plastic. It could also be coated with particles, such as diamond dust,or given a surface texture to enhance the friction coefficient ofsurface 201 with penetrating member 202. Surface 202 could be made of orcoated with diamond, fluorinated ethylene propylene, perfluoroalkoxy, acopolymer of ethylene and tetrafluoroethylene, a copolymer of ethyleneand chlorotrifluoroethylene, or any other material with a coefficient offriction with penetrating member 202 lower than that of the materialused for surface 201.

Referring to FIG. 16, a portion of a base plate 210 of an embodiment ofa penetrating member cartridge is shown with a plurality of penetratingmember slots 212 disposed in a radial direction cut into a top surface214 of the base plate. A drive member 216 is shown with a distal edge218 disposed within one of the penetrating member slots 212 of the baseplate 210. The distal edge 218 of the drive member 216 is configured toslide within the penetrating member slots 212 with a minimum of frictionbut with a close fit to minimize lateral movement during a lancingcycle.

FIG. 17 shows a distal portion 220 of a coated penetrating member 222 inpartial longitudinal section. The coated penetrating member 222 has acore portion 224, a coating 226 and a tapered distal end portion 228. Aportion of a coated drive member 230 is shown having a coating 234 withpenetrating member contact surface 236. The penetrating member contactsurface 236 forms an interface 238 with an outer surface 240 of thecoated penetrating member 222. The interface 238 has a characteristicfriction coefficient that will depend in part on the choice of materialsfor the penetrating member coating 226 and the drive member coating 234.If silver is used as the penetrating member and drive member coating 226and 236, this yields a friction coefficient of about 1.3 to about 1.5.Other materials can be used for coatings 226 and 236 to achieve thedesired friction coefficient. For example, gold, platinum, stainlesssteel and other materials may be used for coatings 226 and 236. It maybe desirable to use combinations of different materials for coatings 226and 236. For example, an embodiment may include silver for a penetratingmember coating 226 and gold for a drive member coating. Some embodimentsof the interface 238 can have friction coefficients of about 1.15 toabout 5.0, specifically, about 1.3 to about 2.0.

Embodiments of the penetrating member 222 can have an outer transversedimension or diameter of about 200 to about 400 microns, specifically,about 275 to about 325 microns. Embodiments of penetrating member 222can have a length of about 10 to about 30 millimeters, specifically,about 15 to about 25 millimeters. Penetrating member 222 can be madefrom any suitable high strength alloy such as stainless steel or thelike.

FIG. 18 is a perspective view of a lancing device 242 having features ofthe invention. A penetrating member cartridge 244 is disposed about adriver 246 that is coupled to a drive member 248 by a coupler rod 250.The penetrating member cartridge 244 has a plurality of penetratingmember slots 252 disposed in a radial configuration in a top surface 254a base plate 256 of the penetrating member cartridge 244. The distalends 253 of the penetrating member slots 252 are disposed at an outersurface 260 of the base plate 256. A fracturable sterility barrier 258,shown partially cut away, is disposed on the top surface 254 of baseplate 256 over the plurality of penetrating member slots 252. Thesterility barrier 258 is also disposed over the outer surface 260 of thebase plate 256 in order to seal the penetrating member slots fromcontamination prior to a lancing cycle. A distal portion of apenetrating member 262 is shown extending radially from the penetratingmember cartridge 244 in the direction of a patients finger 264.

FIG. 19 illustrates a portion of the base plate 256 used with thelancing device 242 in more detail and without sterility barrier 258 inplace (for ease of illustration). The base plate 256 includes aplurality of penetrating member slots 252 which are in radial alignmentwith corresponding drive member slots 266. The drive member slots 266have an optional tapered input configuration that may facilitatealignment of the drive member 248 during downward movement into thedrive member slot 266 and penetrating member slot 252. Penetratingmember slots 252 are sized and configured to accept a penetrating member262 disposed therein and allow axial movement of the penetrating member262 within the penetrating member slots 252 without substantial lateralmovement.

Referring again to FIG. 18, in use, the present embodiment ofpenetrating member cartridge 242 is placed in an operationalconfiguration with the driver 246. A lancing cycle is initiated and thedrive member 248 is brought down through the sterility barrier 258 andinto a penetrating member slot 252. A penetrating member contact surfaceof the drive member then makes contact with an outside surface of thepenetrating member 262 and is driven distally toward the patient'sfinger 264 as described above with regard to the embodiment discussed inFIG. 20. The friction coefficient between the penetrating member contactsurface of the drive member 248 and the penetrating member 262 isgreater than the friction coefficient between the penetrating member 262and an interior surface of the penetrating member slots 252. As such,the drive member 248 is able to drive the penetrating member 262distally through the sterility barrier 258 and into the patient's finger264 without any relative movement or substantial relative movementbetween the drive member 248 and the penetrating member 262.

Referring to FIGS. 20-22, a lancing cycle sequence is shown for alancing device 242 with another embodiment of a penetrating membercartridge 244 as shown in FIGS. 23 and 24. The base plate 256 of thepenetrating member cartridge 242 shown in FIGS. 23 and 24 has aplurality of penetrating member slots 252 with top openings 268 that donot extend radially to the outer surface 260 of the base plate 256. Inthis way, the penetrating member slots 252 can be sealed with a firststerility barrier 270 disposed on the top surface 254 of the base plate256 and a second sterility barrier 272 disposed on the outer surface 260of the base plate 256. Penetrating member outlet ports 274 are disposedat the distal ends of the penetrating member slots 252.

Referring again to FIG. 20, the penetrating member 262 is shown in theproximally retracted starting position within the penetrating memberslot 252. The outer surface of the penetrating member 276 is in contactwith the penetrating member contact surface 278 of the drive member 248.The friction coefficient between the penetrating member contact surface278 of the drive member 248 and the outer surface 276 of the penetratingmember 262 is greater than the friction coefficient between thepenetrating member 262 and an interior surface 280 of the penetratingmember slots 252. A distal drive force as indicated by arrow 282 in FIG.10 is then applied via the drive coupler 250 to the drive member 248 andthe penetrating member is driven out of the penetrating member outletport 274 and into the patient's finger 264. A proximal retraction force,as indicated by arrow 284 in FIG. 22, is then applied to the drivemember 248 and the penetrating member 262 is withdrawn from thepatient's finger 264 and back into the penetrating member slot 252.

FIGS. 25 and 26 illustrate an embodiment of a multiple layer sterilitybarrier 258 in the process of being penetrated by a penetrating member62. It should be understood that this barrier 258 may be adapted for usewith any embodiment of the present invention. The sterility barrier 258shown in FIGS. 25 and 26 is a two layer sterility barrier 258 thatfacilitates maintaining sterility of the penetrating member 262 as itpasses through and exits the sterility barrier 258. In FIG. 25, thedistal end 286 of the penetrating member 262 is applying an axial forcein a distal direction against an inside surface 288 of a first layer 290of the sterility barrier 258, so as to deform the first layer 290 of thesterility barrier 258. The deformation 291 of the first layer 290 inturn applies a distorting force to the second layer 292 of the sterilitybarrier 258. The second layer of the sterility barrier is configured tohave a lower tensile strength that the first layer 290. As such, thesecond layer 292 fails prior to the first layer 290 due to the strainimposed on the first layer 290 by the distal end 286 of the penetratingmember 262, as shown in FIG. 26. After the second layer 292 fails, itthen retracts from the deformed portion 291 of the first layer 290 asshown by arrows 294 in FIG. 26. As long as the inside surface 288 andoutside surface 296 of the first layer 290 are sterile prior to failureof the second layer 292, the penetrating member 262 will remain sterileas it passes through the first layer 290 once the first layer eventuallyfails. Such a multiple layer sterility barrier 258 can be used for anyof the embodiments discussed herein. The multiple layer sterilitybarrier 258 can also include three or more layers.

Referring to FIGS. 27 and 28, an embodiment of a drive member 300coupled to a driver 302 wherein the drive member 300 includes a cuttingmember 304 having a sharpened edge 306 which is configured to cutthrough a sterility barrier 258 of a penetrating member slot 252 duringa lancing cycle in order for the drive member 300 to make contact with apenetrating member. An optional lock pin 308 on the cutting member 304can be configured to engage the top surface 310 of the base plate 312 inorder to prevent distal movement of the cutting member 304 with thedrive member 300 during a lancing cycle.

FIGS. 29 and 30 illustrate an embodiment of a penetrating member slot316 in longitudinal section having a ramped portion 318 disposed at adistal end 320 of the penetrating member slot. A drive member 322 isshown partially disposed within the penetrating member slot 316. Thedrive member 322 has a cutting edge 324 at a distal end 326 thereof forcutting through a sterility barrier 328 during a lancing cycle. FIG. 30illustrates the cutting edge 324 cutting through the sterility barrier328 during a lancing cycle with the cut sterility barrier 328 peelingaway from the cutting edge 324.

FIGS. 31-34 illustrate drive member slots in a base plate 330 of apenetrating member cartridge wherein at least a portion of the drivemember slots have a tapered opening which is larger in transversedimension at a top surface of the base plate than at the bottom of thedrive member slot. FIG. 31 illustrates a base plate 330 with apenetrating member slot 332 that is tapered at the input 334 at the topsurface 336 of the base plate 330 along the entire length of thepenetrating member slot 332. In such a configuration, the penetratingmember slot and drive member slot (not shown) would be in communicationand continuous along the entire length of the slot 332. As an optionalalternative, a base plate 338 as shown in FIGS. 32 and 33 can have adrive member slot 340 that is axially separated from the correspondingpenetrating member slot 342. With this configuration, the drive memberslot 340 can have a tapered configuration and the penetrating memberslot 342 can have a straight walled configuration. In addition, thisconfiguration can be used for corrugated embodiments of base plates 346as shown in FIG. 34. In FIG. 34, a drive member 348 is disposed within adrive member slot 350. A penetrating member contact surface 352 isdisposed on the drive member 348. The contact surface 352 has a taperedconfiguration that will facilitate lateral alignment of the drive member348 with the drive member slot 350.

FIGS. 35-37 illustrate an embodiment of a penetrating member cartridge360 and drive member 362 wherein the drive member 362 has contoured jaws364 configured to grip a penetrating member shaft 366. In FIG. 35, thedrive member 362 and penetrating member shaft 366 are shown intransverse cross section with the contoured jaws 364 disposed about thepenetrating member shaft 366. A pivot point 368 is disposed between thecontoured jaws 364 and a tapered compression slot 370 in the drivemember 362. A compression wedge 372 is shown disposed within the taperedcompression slot 370. Insertion of the compression wedge 372 into thecompression slot 370 as indicated by arrow 374, forces the contouredjaws 364 to close about and grip the penetrating member shaft 366 asindicated by arrows 376.

FIG. 36 shows the drive member 362 in position about a penetratingmember shaft 366 in a penetrating member slot 378 in the penetratingmember cartridge 360. The drive member can be actuated by the methodsdiscussed above with regard to other drive member and driverembodiments. FIG. 37 is an elevational view in longitudinal section ofthe penetrating member shaft 166 disposed within the penetrating memberslot 378. The arrows 380 and 382 indicate in a general way, the pathfollowed by the drive member 362 during a lancing cycle. During alancing cycle, the drive member comes down into the penetrating memberslot 378 as indicated by arrow 380 through an optional sterility barrier(not shown). The contoured jaws of the drive member then clamp about thepenetrating member shaft 366 and move forward in a distal direction soas to drive the penetrating member into the skin of a patient asindicated by arrow 382.

FIGS. 38 and 39 show a portion of a lancing device 390 having a lid 392that can be opened to expose a penetrating member cartridge cavity 394for removal of a used penetrating member cartridge 396 and insertion ofa new penetrating member cartridge 398. Depression of button 400 in thedirection indicated by arrow 402 raises the drive member 404 from thesurface of the penetrating member cartridge 396 by virtue of leveraction about pivot point 406. Raising the lid 392 actuates the lever arm408 in the direction indicated by arrow 410 which in turn applies atensile force to cable 412 in the direction indicated by arrow 414. Thisaction pulls the drive member back away from the penetrating membercartridge 396 so that the penetrating member cartridge 396 can beremoved from the lancing device 390. A new penetrating member cartridge398 can then be inserted into the lancing device 390 and the steps abovereversed in order to position the drive member 404 above the penetratingmember cartridge 398 in an operational position.

FIGS. 40 and 41 illustrate a penetrating member cartridge 420 that haspenetrating member slots 422 on a top side 424 and a bottom side 426 ofthe penetrating member cartridge 420. This allows for a penetratingmember cartridge 420 of a diameter D to store for use twice the numberof penetrating members as a one sided penetrating member cartridge ofthe same diameter D.

FIGS. 42-44 illustrate end and perspective views of a penetrating membercartridge 430 having a plurality of penetrating member slots 432 formedfrom a corrugated surface 434 of the penetrating member cartridge 430.Penetrating members 436 are disposed on both sides of the penetratingmember cartridge 430. A sterility barrier 438 is shown disposed over thepenetrating member slots 432 in FIG. 44.

FIGS. 45-48 illustrate embodiments of a penetrating member 440 and drivemember 442 wherein the penetrating member 440 has a transverse slot 444in the penetrating member shaft 446 and the drive member 442 has aprotuberance 448 configured to mate with the transverse slot 444 in thepenetrating member shaft 446. FIG. 45 shows a protuberance 448 having atapered configuration that matches a tapered configuration of thetransverse slot 444 in the penetrating member shaft 446. FIG. 46illustrates an optional alternative embodiment wherein the protuberance448 has straight walled sides that are configured to match the straightwalled sides of the transverse slot 444 shown in FIG. 46. FIG. 47 showsa tapered protuberance 448 that is configured to leave an end gap 450between an end of the protuberance 448 and a bottom of the transverseslot in the penetrating member shaft 446.

FIG. 48 illustrates a mechanism 452 to lock the drive member 442 to thepenetrating member shaft 446 that has a lever arm 454 with an optionalbearing 456 on the first end 458 thereof disposed within a guide slot459 of the drive member 442. The lever arm 454 has a pivot point 460disposed between the first end 458 of the lever arm 454 and the secondend 462 of the lever arm 454. A biasing force is disposed on the secondend 462 of the lever arm 454 by a spring member 464 that is disposedbetween the second end 462 of the lever arm 454 and a base plate 466.The biasing force in the direction indicated by arrow 468 forces thepenetrating member contact surface 470 of the drive member 442 againstthe outside surface of the penetrating member 446 and, in addition,forces the protuberance 448 of the drive member 442 into the transverseslot 444 of the penetrating member shaft 446.

Referring now to FIG. 49, another embodiment of a replaceable cartridge500 suitable for housing a plurality of individually moveablepenetrating members (not shown) will be described in further detail.Although cartridge 500 is shown with a chamfered outer periphery, itshould also be understood that less chamfered and unchamferedembodiments of the cartridge 500 may also be adapted for use with anyembodiment of the present invention disclosed herein. The penetratingmembers slidably coupled to the cartridge may be a bare lancet or bareelongate member without outer molded part or body pieces as seen inconventional lancet. The bare design reduces cost and simplifiesmanufacturing of penetrating members for use with the present invention.The penetrating members may be retractable and held within the cartridgeso that they are not able to be used again. The cartridge is replaceablewith a new cartridge once all the piercing members have been used. Thelancets or penetrating members may be fully contained in the usedcartridge so at to minimize the chance of patient contact with suchwaste.

As can be seen in FIG. 49, the cartridge 500 may include a plurality ofcavities 501 for housing a penetrating member. In this embodiment, thecavity 501 may have a longitudinal opening 502 associated with thecavity. The cavity 501 may also have a lateral opening 503 allowing thepenetrating member to exit radially outward from the cartridge. As seenin FIG. 49, the outer radial portion of the cavity may be narrowed. Theupper portion of this narrowed area may also be sealed or swaged toclose the top portion 505 and define an enclosed opening 506 as shown inFIG. 50. Optionally, the narrowed area 504 may retain an open topconfiguration, though in some embodiments, the foil over the gap isunbroken, preventing the penetrating member from lifting up or extendingupward out of the cartridge. The narrowed portion 504 may act as abearing and/or guide for the penetrating member. FIG. 51 shows that theopening 506 may have a variety of shapes such as but not limited to,circular, rectangular, triangular, hexagonal, square, or combinations ofany or all of the previous shapes. Openings 507 (shown in phantom) forother microfluidics, capillary tubes, or the like may also beincorporated in the immediate vicinity of the opening 506. In someoptional embodiments, such openings 507 may be configured to surroundthe opening 506 in a concentric or other manner.

Referring now to FIG. 52, the underside of a cartridge 500 will bedescribed in further detail. This figures shows many features on onecartridge 500. It should be understood that a cartridge may includesome, none, or all of these features, but they are shown in FIG. 52 forease of illustration. The underside may include indentations or holes510 close to the inner periphery for purpose of properly positioning thecartridge to engage a penetrating member gripper and/or to allow anadvancing device (shown in FIGS. 56B and 56C) to rotate the cartridge500. Indentations or holes 511 may be formed along various locations onthe underside of cartridge 500 and may assume various shapes such as butnot limited to, circular, rectangular, triangular, hexagonal, square, orcombinations of any or all of the previous shapes. Notches 512 may alsobe formed along the inner surface of the cartridge 500 to assist inalignment and/or rotation of the cartridge. It should be understood ofcourse that some of these features may also be placed on the topside ofthe cartridge in areas not occupied by cavities 501 that house thepenetrating members. Notches 513 may also be incorporated along theouter periphery of the cartridge. These notches 513 may be used togather excess material from the sterility barrier 28 (not shown) thatmay be used to cover the angled portion 514 of the cartridge. In thepresent embodiment, the cartridge has a flat top surface and an angledsurface around the outside. Welding a foil type sterility barrier overthat angled surface, the foil folds because of the change in thesurfaces which is now at 45 degrees. This creates excess material. Thegrooves or notches 513 are there as a location for that excess material.Placing the foil down into those grooves 513 which may tightly stretchthe material across the 45 degree angled surface. Although in thisembodiment the surface is shown to be at 45 degrees, it should beunderstood that other angles may also be used. For example, the surfacemay be at any angle between about 3 degrees to 90 degrees, relative tohorizontal. The surface may be squared off. The surface may beunchamfered. The surface may also be a curved surface or it may becombinations of a variety of angled surfaces, curved and straightssurfaces, or any combination of some or all of the above.

Referring now to FIGS. 53-54, the sequence in which the cartridge 500 isindexed and penetrating members are actuated will now be described. Itshould be understood that some steps described herein may be combined ortaken out of order without departing from the spirit of the invention.These sequence of steps provides vertical and horizontal movement usedwith the present embodiment to load a penetrating member onto thedriver.

As previously discussed, each cavity on the cartridge may beindividually sealed with a foil cover or other sterile enclosurematerial to maintain sterility until or just before the time of use. Inthe present embodiment, penetrating members are released from theirsterile environments just prior to actuation and are loaded onto alauncher mechanism for use. Releasing the penetrating member from thesterile environment prior to launch allows the penetrating member in thepresent embodiment to be actuated without having to pierce any sterileenclosure material which may dull the tip of the penetrating member orplace contaminants on the member as it travels towards a target tissue.A variety of methods may be used accomplish this goal.

FIG. 53A shows one embodiment of penetrating member release device,which in this embodiment is a punch plate 520 that is shown in asee-through depiction for ease of illustration. The punch plate 520 mayinclude a first portion 521 for piercing sterile material covering thelongitudinal opening 502 and a second portion 522 for piercing materialcovering the lateral opening 503. A slot 523 allows the penetratingmember gripper to pass through the punch plate 520 and engage apenetrating member housed in the cartridge 500. The second portion 522of the punch plate down to engage sterility barrier angled at about a 45degree slope. Of course, the slope of the barrier may be varied. Thepunch portion 522 first contacts the rear of the front pocket sterilitybarrier and as it goes down, the cracks runs down each side and thebarrier is pressed down to the bottom of the front cavity. The rear edgeof the barrier first contacted by the punch portion 522 is broken offand the barrier is pressed down, substantially cleared out of the way.These features may be more clearly seen in FIG. 53B. The punch portion521 may include a blade portion down the centerline. As the punch comesdown, that blade may be aligned with the center of the cavity, cuttingthe sterility barrier into two pieces. The wider part of the punch 521then pushes down on the barrier so the they align parallel to the sidesof the cavity. This creates a complete and clear path for the gripperthroughout the longitudinal opening of the cavity. Additionally, as seenin FIGS. 53B and 54A, a plurality of protrusion 524 are positioned toengage a cam (FIG. 55A) which sequences the punching and other verticalmovement of punch plate 520 and cartridge pusher 525. The drive shaft526 from a force generator (not shown) which is used to actuate thepenetrating member 527.

Referring now to FIGS. 54A-F, the release and loading of the penetratingmembers are achieved in the following sequence. FIG. 54A shows therelease and loading mechanism in rest state with a dirty barepenetrating member 527 held in a bare penetrating member gripper 530.This is the condition of the device between lancing events. When thetime comes for the patient to initiate another lancing event, the usedpenetrating member is cleared and a new penetrating member is loaded,just prior to the actual lancing event. The patient begins the loadingof a new penetrating member by operating a setting lever to initiate theprocess. The setting lever may operate mechanically to rotate a cam (seeFIG. 55A) that moves the punch plate 520 and cartridge pusher 525. Inother embodiments, a stepper motor or other mover such as but notlimited to, a pneumatic actuator, hydraulic actuator, or the like areused to drive the loading sequence.

FIG. 54B shows one embodiment of penetrating member gripper 530 in moredetail. The penetrating member gripper 530 may be in the form of atuning fork with sharp edges along the inside of the legs contacting thepenetrating member. In some embodiments, the penetrating member may benotched, recessed, or otherwise shaped to receive the penetrating membergripper. As the gripper 530 is pushed down on the penetrating member,the legs are spread open elastically to create a frictional grip withthe penetrating member such as but not limited to bare elongate wireswithout attachments molded or otherwise attached thereon. In someembodiments, the penetrating member is made of a homogenous materialwithout any additional attachments that are molded, adhered, glued orotherwise added onto the penetrating member.

In some embodiments, the gripper 530 may cut into the sides of thepenetrating member. The penetrating member in one embodiment may beabout 300 microns wide. The grooves that form in the side of thepenetrating member by the knife edges are on the order of about 5-10microns deep and are quite small. In this particular embodiment, theknife edges allow the apparatus to use a small insertion force to getthe gripper onto the penetrating member, compared to the force to removethe penetrating member from the gripper the longitudinal axis of anelongate penetrating member. Thus, the risk of a penetrating memberbeing detached during actuation are reduced. The gripper 530 may be madeof a variety of materials such as, but not limited to high strengthcarbon steel that is heat treated to increased hardness, ceramic,substrates with diamond coating, composite reinforced plastic,elastomer, polymer, and sintered metals. Additionally, the steel may besurface treated. The gripper 130 may have high gripping force with lowfriction drag on solenoid or other driver.

As seen in FIG. 54C, the sequence begins with punch plate 520 beingpushed down. This results in the opening of the next sterile cavity 532.In some embodiment, this movement of punch plate 520 may also result inthe crimping of the dirty penetrating member to prevent it from beingused again. This crimping may result from a protrusion on the punchplate bending the penetrating member or pushing the penetrating memberinto a groove in the cartridge that hold the penetrating member in placethrough an interference fit. As seen in FIGS. 53B and 54C, the punchplate 520 has a protrusion or punch shaped to penetrate a longitudinalopening 502 and a lateral opening 503 on the cartridge. The firstportion 521 of the punch that opens cavity 532 is shaped to first piercethe sterility barrier and then push, compresses, or otherwise movessterile enclosure material towards the sides of the longitudinal opening502. The second portion 522 of the punch pushes down the sterilitybarrier at lateral opening or penetrating member exit 503 such that thepenetrating member does not pierce any materials when it is actuatedtoward a tissue site.

Referring now to FIG. 54D, the cartridge pusher 525 is engaged by thecam 550 (not shown) and begins to push down on the cartridge 500. Thepunch plate 520 also travels downward with the cartridge 500 until it ispushed down to it maximum downward position, while the penetratingmember gripper 53.0 remains vertically stationary. This joint downwardmotion away from the penetrating member gripper 530 will remove thepenetrating member from the gripper. The punch plate 520 essentiallypushes against the penetrating member with protrusion 534 (FIG. 55A),holding the penetrating member with the cartridge, while the cartridge500 and the punch plate 520 is lowered away from the penetrating membergripper 530 which in this embodiment remains vertically stationary. Thiscauses the stripping of the used penetrating member from the gripper 530(FIG. 45D) as the cartridge moves relative to the gripper.

At this point as seen in FIG. 54E, the punch plate 520 retracts upwardand the cartridge 500 is pushed fully down, clear of the gripper 530.Now cleared of obstructions and in a rotatable position, the cartridge500 increments one pocket or cavity in the direction that brings thenewly released, sterile penetrating member in cavity 532 into alignmentwith the penetrating member gripper 530, as see in FIG. 54F. Therotation of the cartridge occurs due to fingers engaging the holes orindentations 533 on the cartridge, as seen in FIG. 54A. In someembodiments, these indentations 533 do not pass completely throughcartridge 500. In other embodiments, these indentations are holespassing completely through. The cartridge has a plurality of littleindentations 533 on the top surface near the center of the cartridge,along the inside diameter. In the one embodiment, the sterility barrieris cut short so as not to cover these plurality of indentations 533. Itshould be understood of course that these holes may be located onbottom, side or other accessible surface. These indentations 533 havetwo purposes. The apparatus may have one or a plurality of locator pins,static pins, or other keying feature that dos not move. In thisembodiment, the cartridge will only set down into positions where thegripper 530 is gripping the penetrating member. To index the cassette,the cartridge is lifted off those pins or other keyed feature, rotatedaround, and dropped onto those pins for the next position. The rotatingdevice is through the use of two fingers: one is a static pawl and theother one is a sliding finger. They engage with the holes 533. Thefingers are driven by a slider that may be automatically actuated oractuated by the user. This maybe occur mechanically or through electricor other powered devices. Halfway through the stroke, a finger mayengage and rotate around the cartridge. A more complete description canbe found with text associated with FIGS. 56B-56C.

Referring now to FIG. 54G, with the sterile penetrating member inalignment, the cartridge 500 is released as indicated by arrows 540 andbrought back into contact with the penetrating member gripper 530. Thenew penetrating member 541 is inserted into the gripper 530, and theapparatus is ready to fire once again. After launch and in betweenlancing events for the present embodiment, the bare lancet orpenetrating member 541 is held in place by gripper 530, preventing thepenetrating member from accidentally protruding or sliding out of thecartridge 500.

It should be understood of course, that variations can be added to theabove embodiment without departing from the spirit of the invention. Forexample, the penetrating member 541 may be placed in a parked positionin the cartridge 500 prior to launch. As seen in FIG. 55A, thepenetrating member is held by a narrowed portion 542 of the cartridge,creating an interference fit which pinches the proximal end of thepenetrating member. Friction from the molding or cartridge holds thepenetrating member during rest, preventing the penetrating member fromsliding back and forth. Of course, other methods of holding thepenetrating member may also be used. As seen in FIG. 55B prior tolaunch, the penetrating member gripper 530 may pull the penetratingmember 541 out of the portion 542. The penetrating member 541 may remainin this portion until actuated by the solenoid or other force generatorcoupled to the penetrating member gripper. A cam surface 544 may be usedto pull the penetrating member out of the portion 542. This mechanicalcam surface may be coupled to the mechanical slider driven by thepatient, which may be considered a separate force generator. Thus,energy from the patient extracts the penetrating member and this reducesthe drain on the device's battery if the solenoid or electric driverwere to pull out the penetrating member. The penetrating member may bemoved forward a small distance (on the order of about 1 mm or less) fromits parked position to pull the penetrating member from the restposition gripper. After penetrating tissue, the penetrating member maybe returned to the cartridge and eventually placed into the parkedposition. This may also occur, though not necessarily, through forceprovided by the patient. In one embodiment, the placing of the lancetinto the parked position does not occur until the process for loading anew penetrating member is initiated by the patient. In otherembodiments, the pulling out of the parked position occurs in the samemotion as the penetrating member actuation. The return into the parkedposition may also be considered a continuous motion.

FIG. 55A also shows one embodiment of the cam and other surfaces used tocoordinate the motion of the punch plate 520. For example, cam 550 inthis embodiment is circular and engages the protrusions 524 on the punchplate 520 and the cartridge pusher 525. FIG. 55A also more clearly showsprotrusion 534 which helps to hold the penetrating member in thecartridge 500 while the penetrating member gripper 530 pulls away fromthe member, relatively speaking. A ratchet surface 552 that rotates withthe cam 550 may be used to prevent the cam from rotating backwards. Theraising and lower of cartridge 500 and punch plate 50 used toload/unload penetrating members may be mechanically actuated by avariety of cam surfaces, springs, or the like as may be determined byone skilled in the art. Some embodiments may also use electrical ormagnetic device to perform the loading, unloading, and release of barepenetrating members. Although the punch plate 520 is shown to bepunching downward to displace, remove, or move the foil or other sterileenvironment enclosure, it should be understood that other methods suchas stripping, pulling, tearing, or some combination of one or more ofthese methods may be used to remove the foil or sterile enclosure. Forexample, in other embodiments, the punch plate 520 may be located on anunderside of the cartridge and punch upward. In other embodiments, thecartridge may remain vertically stationary while other parts such as thepenetrating member gripper and punch plate move to load a sterilepenetrating member on to the penetrating member gripper.

FIG. 55B also shows other features that may be included in the presentapparatus. A fire button 560 may be included for the user to actuate thepenetrating member. A front end interface 561 may be included to allow apatient to seat their finger or other target tissue for lancing. Theinterface 561 may be removable to be cleaned or replaced. A visualdisplay 562 may be included to show device status, lancing performance,error reports, or the like to the patient.

Referring now to FIG. 56A, a mechanical slider 564 used by the patientto load new penetrating member may also be incorporated on the housing.The slider 564 may also be coupled to activate an LCD or visual displayon the lancing apparatus. In addition to providing a source of energy toindex the cartridge, the slider 564 may also switch the electronics tostart the display. The user may use the display to select the depth oflancing or other feature. The display may go back to sleep again untilit is activated again by motion of the slider 564. The underside thehousing 566 may also be hinged or otherwise removable to allow theinsertion of cartridge 500 into the device. The cartridge 500 may beinserted using technology current used for insertion of a compact discor other disc into a compact disc player. In one embodiment, there maybe a tray which is deployed outward to receive or to remove a cartridge.The tray may be withdrawn into the apparatus where it may be elevated,lowered, or otherwise transported into position for use with thepenetrating member driver. In other embodiments, the apparatus may havea slot into which the cartridge is partially inserted at which point amechanical apparatus will assist in completing insertion of thecartridge and load the cartridge into proper position inside theapparatus. Such device is akin to the type of compact disc player foundon automobiles. The insertions/ejection and loading apparatus of thesecompact disc players uses gears, pulleys, cables, trays, and/or otherparts that may be adapted for use with the present invention.

Referring now to FIG. 56B, a more detailed view of one embodiment of theslider 564 is provided. In this embodiment, the slider 564 will moveinitially as indicated by arrow 567. To complete the cycle, the patientwill return the slider to its home position or original startingposition as indicated by arrow 568. The slider 564 has an arm 569 whichmoves with the slider to rotate the cam 550 and engage portions 522. Themotion of the slider 564 is also mechanically coupled to a finger 570which engage the indentations 571 on cartridge 500. The finger 570 issynchronized to rotate the cartridge 500 by pulling as indicated byarrow 572 in the same plane as the cartridge. It should be understoodthat in some embodiments, the finger 570 pushes instead of pulls torotate the cartridge in the correct direction. The finger 570 may alsobe adapted to engage ratchet surfaces 706 as seen in FIG. 66 to rotate acartridge. The finger 570 may also incorporate vertical motion tocoordinate with the rising and lowering of the cartridge 500. The motionof finger 570 may also be powered by electric actuators such as astepper motor or other device useful for achieving motion. FIG. 56B alsoshows a portion of the encoder 573 used in position sensing.

Referring now to FIG. 56C, a still further view of the slider 564 andarm 569 is shown. The arm 569 moves to engage portion 522 as indicatedby arrow 575 and this causes the cam 550 to rotate as indicated by arrow577. In this particular embodiment, the cam 550 rotates about ⅛ of anrotation with each pull of the slider 564. When the slider 564 is returnto its home or start position, the arm 569 rides over the portion 522.The movement of the slider also allows the cam surface 544 to rotateabout pivot point 579. A resilient member 580 may be coupled to the camsurface 544 to cause it to rotate counterclockwise when the arm 569moves in the direction of arrow 567. The pin 580 will remain in contactwith the arm 569. As the cam surface 544 rotates a first surface 582will contact the pin 583 on the gripper block 584 and pull the pin 583back to park a penetrating member into a coupling or narrowed portion542 of the cartridge 500 as seen in FIG. 55A. As the arm 569 is broughtback to the home position, the cam surface 544 rotates back and a secondsurface 586 that rotates clockwise and pushes the penetrating memberforward to be released from the narrowed portion 542 resulting in aposition as seen in FIG. 55B. It should be understood that in someembodiments, the release and/or parking of lancet from portion 542 maybe powered by the driver 588 without using the mechanical assistancefrom cam surface 544.

In another embodiment of the cartridge device, a mechanical feature maybe included on the cartridge so that there is only one way to load itinto the apparatus. For example, in one embodiment holding 50penetrating members, the cartridge may have 51 pockets or cavities. The51^(st) pocket will go into the firing position when the device isloaded, thus providing a location for the gripper to rest in thecartridge without releasing a penetrating member from a sterileenvironment. The gripper 530 in that zeroth position is inside thepocket or cavity and that is the reason why one of the pockets may beempty. Of course, some embodiments may have the gripper 530 positionedto grip a penetrating member as the cartridge 500 is loaded into thedevice, with the patient lancing themselves soon afterwards so that thepenetrating member is not contaminated due to prolonged exposure outsidethe sterile enclosure. That zeroth position may be the start and finishposition. The cartridge may also be notched to engaged a protrusion onthe apparatus, thus also providing a method for allowing the penetratingmember to loaded or unloaded only in one orientation. Essentially, thecartridge 500 may be keyed or slotted in association with the apparatusso that the cartridge 500 can only be inserted or removed at oneorientation. For example as seen in FIG. 56D, the cartridge 592 may havea keyed slot 593 that matches the outline of a protrusion 594 such thatthe cartridge 592 may only be removed upon alignment of the slot 593 andprotrusion 594 upon at the start or end positions. It should beunderstood that other keyed technology may be used and the slot or keymay be located on an outer periphery or other location on the cartridge592 in manner useful for allowing insertion or removal of the cartridgefrom only one or a select number of orientations.

Referring now to FIG. 57, a cross-section of another embodiment of acavity 600 housing a penetrating member is shown. The cavity 600 mayinclude a depression 602 for allowing the bare penetrating membergripper 530 to penetrate sufficiently deeply into the cavity tofrictionally engage the penetrating member 541. The penetrating membermay also be housed in a groove 604 that holds the penetrating member inplace prior to and after actuation. The penetrating member 541 is liftedupward to clear the groove 604 during actuation and exits throughopening 506.

Referring now to FIG. 58, another variation on the system according tothe present invention will now be described. FIG. 58 shows a lancingsystem 610 wherein the penetrating members have their sharpened tippointed radially inward. The finger or other tissue of the patient isinserted through the center hole 611 to be pierced by the member 612.The bare penetrating member gripper 530 coupled to drive force generator613 operate in substantially the same manner as described in FIGS.54A-G. The punch portions 521 and 522 operate in substantially the samemanner to release the penetrating members from the sterile enclosures.The punch portion 522 may be placed on the inner periphery of thedevice, where the penetrating member exit is now located, so thatsterile enclosure material is cleared out of the path of the penetratingmember exit.

Referring now to FIG. 59, a still further variation on the lancingsystem according to the present invention will now be described. In theembodiments shown in FIGS. 53-54, the bare penetrating member gripper530 approaches the penetrating member from above and at least a portionof the drive system is located in a different plane from that of thecartridge 500. FIG. 59 shows an embodiment where the penetrating memberdriver 620 is in substantially the same plane as the penetrating member622. The coupler 624 engages a bent or L shaped portion 626 of themember 622. The cartridge 628 can rotate to engage a new penetratingmember with the coupler 624 without having to move the cartridge orcoupler vertically. The next penetrating member rotates into position inthe slot provided by the coupler 624. A narrowed portion of thecartridge acts as a penetrating member guide 630 near the distal end ofthe penetrating member to align the penetrating member as it exits thecartridge.

The coupler 624 may come in a variety of configurations. For example,FIG. 60A shows a coupler 632 which can engage a penetrating member 633that does not have a bent or L-shaped portion. A radial cartridgecarrying such a penetrating member 633 may rotate to slide penetratingmember into the groove 634 of the coupler 632. FIG. 60B is a front viewshowing that the coupler 632 may include a tapered portion 636 to guidethe penetrating member 633 into the slot 634. FIG. 60C shows anembodiment of the driver 620 using a coupler 637 having a slot 638 forreceiving a T-shaped penetrating member. The coupler 637 may furtherinclude a protrusion 639 that may be guided in an overhead slot tomaintain alignment of the drive shaft during actuation.

Referring now to FIG. 61, a cartridge 640 for use with an in-planedriver 620 is shown. The cartridge 640 includes an empty slot 642 thatallows the cartridge to be placed in position with the driver 620. Inthis embodiment, the empty slot 642 allows the coupler 644 to bepositioned to engage an unused penetrating member 645 that may berotated into position as shown by arrow 646. As seen in FIG. 61, thecartridge 640 may also be designed so that only the portion of thepenetrating member that needs to remain sterile (i.e. the portions thatmay actually be penetrating into tissue) are enclosed. As seen in FIG.61, a proximal portion 647 of the penetrating member is exposed. Thisexposed proximal portion may be about 70% of the penetrating member. Inother embodiments it may be between about 69% to about 5% of thepenetrating member. The cartridge 640 may further include, but notnecessarily, sealing protrusions 648. These protrusions 648 arereleasably coupled to the cartridge 640 and are removed from thecartridge 640 by remover 649 as the cartridge rotates to placepenetrating member 645 into the position of the active penetratingmember. The sterile environment is broken prior to actuation of themember 645 and the member does not penetrate sterile enclosure materialthat may dull the tip of the penetrating member during actuation. Afracturable seal material 650 may be applied to the member to sealagainst an inner peripheral portion of the cartridge.

Referring now to FIG. 62, a still further embodiment of a cartridge foruse with the present invention will be described. This cartridge 652includes a tapered portion 654 for allowing the coupler 655 to enter thecavity 656. A narrowed portion 657 guides the penetrating member 658.The coupler 655 may have, but does not necessarily have, movable jaws659 that engage to grip the penetrating member 658. Allowing the couplerto enter the cavity 656 allows the alignment of the penetrating memberto be better maintained during actuation. This tapered portion 654 maybe adapted for use with any embodiment of the cartridge disclosedherein.

Referring now to FIG. 63, a linear cartridge 660 for use with thepresent invention will be described. Although the present invention hasbeen shown in use with radial cartridges, the lancing system may beadapted for use with cartridges of other shapes. FIGS. 79-83 show othercartridges of varying shapes adaptable for use with the presentinvention. FIG. 63 illustrates a cartridge 660 with only a portion 662providing sterile protection for the penetrating members. The cartridge660, however, provides a base 664 on which a penetrating member 665 canrest. This provides a level of protection of the penetrating memberduring handling. The base 664 may also be shaped to provide slots 666 inwhich a penetrating member 667 may be held. The slot 666 may also beadapted to have a tapered portion 668. These configurations may beadapted for use with any of the embodiments disclosed herein, such asthe cartridge 652.

Referring now to FIGS. 64A-64C, a variety of different devices are shownfor releasing the sterility seal covering a lateral opening 503 on thecartridge 500. FIG. 64A shows a rotating punch device 670 that hasprotrusions 672 that punch out the sterility barrier creating openings674 from which a penetrating member can exit without touching thesterility barrier material. FIG. 64B shows a vertically rotating device676 with shaped protrusions 678 that punch down the sterility barrier679 as it is rotated to be in the active, firing position. FIG. 64Cshows a punch 680 which is positioned to punch out barrier 682 when thecartridge is lowered onto the punch. The cartridge is rotated and thepunch 680 rotates with the cartridge. After the cartridge is rotated tothe proper position and lifted up, the punch 680 is spring loaded orotherwise configured to return to the position to engage the sterilitybarrier covering the next unused penetrating member.

Referring now to FIGS. 65A-65B, another type of punch mechanism for usewith a punch plate 520 will now be described. The device shown in FIGS.53-54 shows a mechanism that first punches and then rotates or indexesthe released penetrating member into position. In this presentembodiment, the cartridge is rotated first and then the gripper andpunch may move down simultaneously. FIG. 65A shows a punch 685 having afirst portion 686 and a second portion 687. As seen in cross-sectionalview of FIG. 65B, the penetrating member gripper 690 is located insidethe punch 685. Thus the penetrating of the sterility barrier isintegrated into the step of engaging the penetrating member with thegripper 690. The punch 685 may include a slot 692 allowing a portion 694of the gripper 690 to extend upward. A lateral opening 695 is providedfrom which a penetrating member may exit. In some embodiments, the punchportion 687 is not included with punch 686, instead relying on someother mechanism such as those shown in FIGS. 64A-64C to press down onbarrier material covering a lateral opening 503.

Referring now to FIG. 66, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 66 shows acartridge 700 with a plurality of cavities 702 and individualdeflectable portions or fingers 704. The ends of the protective cavities702 may be divided into individual fingers (such as one for each cavity)on the outer periphery of the disc. Each finger 704 may be individuallysealed with a foil cover (not shown for ease of illustration) tomaintain sterility until the time of use. Along the inner periphery ofthe cartridge 700 are raised step portions 706 to create a ratchet typemechanism. As seen in FIG. 67, a penetrating member 708 may be housed ineach cavity. The penetrating member may rest on a raised portion 710. Anarrowed portion 712 pinches the proximal portions of the penetrationmember 708. Each cavity may include a wall portion 714 into which thepenetrating member 708 may be driven after the penetrating member hasbeen used. FIG. 68 shows the penetrating member gripper 716 lowered toengage a penetrating member 708. For ease of illustration, a sterilitybarrier covering each of the cavities is not shown.

Referring now to FIGS. 69A-69L, the sequence of steps for actuating apenetrating member in a cartridge 700 will be described. It should beunderstood that in other embodiments, steps may be combined or reducedwithout departing from the sprit of the present invention. The lastpenetrating member to be used may be left in a retracted position,captured by a gripper 716. The end of the protective cavity 704 may bedeflected downward by the previous actuation. The user may operate amechanism such as but not limited to a thumbwheel, lever, crank, slider,etc. . . . that advances a new penetrating member 720 into launchposition as seen in FIG. 69A. The mechanism lifts a bar that allows theprotective cavity to return to its original position in the plane of thedisc.

In this embodiment as shown in FIG. 69B, the penetrating member guide722 presses through foil in rear of pocket to “home” penetrating memberand control vertical clearance. For ease of illustration, actuationdevices for moving the penetrating member guide 722 and other mechanismsare not shown. They may be springs, cams, or other devices that canlower and move the components shown in these figures. In someembodiments, the cartridge 700 may be raised or lowered to engage thepenetrating member guide 722 and other devices.

As seen in FIG. 69C, the plough or sterile enclosure release device 724is lowered to engage the cartridge 700. In some embodiments, the disc orcartridge 700 may raised part way upward until a plough or plow blade724 pierces the sterility barrier 726 which may be a foil covering.

Referring now to FIG. 69D, the plough 724 clears foil from front ofpocket and leaves it attached to cartridge 700. The plough 724 is drivenradially inward, cutting open the sterility barrier and rolling thescrap into a coil ahead of the plough. Foil naturally curls over andforms tight coil when plough lead angle is around 55 degs to horizontal.If angle of the plough may be between about 60-40 degs, preferablycloser to 55 degs. In some embodiments, the foil may be removed in sucha manner that the penetrating member does not need to pierce any sterileenclosure materials during launch.

Referring now to FIG. 69E, the gripper 716 may be lowered to engage thebare penetrating member or piercing member 720. Optionally, the disc orcartridge 8000 may be raised until the penetrating member 720 is pressedfirmly into the gripper 716. Although not shown in the present figure,the penetrating member driver or actuator of the present embodiment mayremain in the same horizontal plane as the penetrating member.

As seen in FIG. 69F, a bar 730 may be pressed downward on the outer end732 of the protective cavity to deflect it so it is clear of the path ofthe penetrating member. In the present embodiment, the bar 730 is shapedto allow the bare penetrating member 720 to pass through. It should beunderstood that other shapes and orientations of the bar (such ascontacting only one side or part of end 732) may be used to engage theend 732.

Referring now to FIG. 69G, an electrical solenoid or other electronic orfeed-back controllable drive may actuate the gripper 716 radiallyoutward, carrying the bare penetrating member 720 with it. The barepenetrating member projects from the protective case and into the skinof a finger or other tissue site that has been placed over the apertureof the actuator assembly. Suitable penetrating member drivers aredescribed in commonly assigned, copending U.S. patent application Ser.No. 10/127,395 filed Apr. 19, 2002.

Referring now to FIG. 69H, the solenoid or other suitable penetratingmember driver retracts the bare penetrating member 720 into a retractedposition where it parks until the beginning of the next lancing cycle.

Referring now to FIG. 69I, bar 730 may be released so that the end 150returns to an in-plane configuration with the cartridge 800.

As seen in FIG. 69J, the gripper 716 may drive a used bare penetratingmember radially outward until the sharpened tip is embedded into aplastic wall 714 at or near the outward end 732 of the cavity thusimmobilizing the contaminated penetrating member.

As seen in FIGS. 69K and 69L, the plough 724, the gripper 716, andpenetrating member guide 722 may all be disengaged from the barepenetrating member 720. Optionally, it should be understood that theadvance mechanism may lower the cartridge 700 from the gripper 716. Theused penetrating member, restrained by the tip embedded in plastic, andby the cover foil at the opposite end, is stripped from the gripper. Thedisc or cartridge 700 may be rotated until a new, sealed; sterilepenetrating member is in position under the launch mechanism.

Referring now to FIGS. 70 and 71, one object for some embodiments of theinvention is to include blood sampling and sensing on this penetratingmember actuation device. In the present embodiment, the drive mechanism(gripper 738 and solenoid drive coil 739) may be used to drive apenetrating member into the skin and couple this lancing event toacquire the blood sample as it forms at the surface of the finger. In afirst embodiment shown in FIG. 70, microfluidic module 740 bearing theanalyte sensor chemistry and detection device 742 (FIG. 71) is couple onto the shaft of the penetrating member 720. The drive cycle describedabove may also actuate the module 740 so that it rests at the surface ofthe finger to acquire blood once the penetrating member retracts fromthe wound. The module 740 is allowed to remain on the surface of thefinger or other tissue site until the gripper 738 has reached the backend 744 of the microfluidics module 740, at which point the module isalso retracted into the casing. The amount of time the module 740remains on the finger, in this embodiment, may be varied based on thedistance the end 744 is located and the amount of time it takes thegripper to engage it on the withdrawal stroke. The blood filled module740, filled while the module remains on pierced tissue site, may thenundergo analyte detection by means such as optical or electrochemicalsensing.

The blood may be filled in the lumen that the penetrating member was inor the module may have separately defined sample chambers to the side ofthe penetrating member lumen. The sensor may also be placed right at theimmediate vicinity or slightly setback from the module opening receivingblood so that low blood volumes will still reach the sensor. In someembodiments, the analyte sensing device and a visual display or otherinterface may be on board the apparatus and thus provide a readout ofanalyte levels without need to plug apparatus or a test strip into aseparate reader device. As seen in FIG. 71, the cover 746 may also beclear to allow for light to pass through for optical sensing. The sensormay be used with low volumes such as less than about 1 microliter ofsample, preferably less than about 0.6 microliter, more preferably lessthan about 0.3 microliter, and most preferably less than about 0.1microliter of sample.

In another embodiment as seen in FIG. 72, sensing elements 760 may bedirectly printed or formed on the top of bottom of the penetratingmember cartridge 700, depending on orientation. The bare penetratingmember 720 is then actuated through a hole 762 in the plastic facing,withdrawn into the radial cavity followed by the blood sample.Electrochemical or optical detection for analyte sensing may then becarried out (FIG. 72). Again the cavity 766 may have a clear portion toallow light to pass for optical sensing. In one embodiment, amultiplicity of miniaturized sensor fields may be placed on the floor ofthe radial cavity as shown in FIG. 72 or on the microfluidic moduleshown in FIG. 71 to allow many tests on a single analyte form a singledrop of blood to improve accuracy and precision of measurement. Althoughnot limited in this manner, additional sensor fields or regions may alsobe included for calibration or other purposes.

Referring now to FIG. 73, a still further embodiment of a cartridgeaccording to the present invention will be described. FIG. 73 shows oneembodiment of a cartridge 800 which may be removably inserted into anapparatus for driving penetrating members to pierce skin or othertissue. The cartridge 800 has a plurality of penetrating members 802that may be individually or otherwise selectively actuated so that thepenetrating members 802 may extend outward from the cartridge, asindicated by arrow 804, to penetrate tissue. In the present embodiment,the cartridge 800 may be based on a flat disc with a number ofpenetrating members such as, but in no way limited to, (25, 50, 75, 100,. . . ) arranged radially on the disc or cartridge 800. It should beunderstood that although the cartridge 800 is shown as a disc or adisc-shaped housing, other shapes or configurations of the cartridge mayalso work without departing from the spirit of the present invention ofplacing a plurality of penetrating members to be engaged by apenetrating member driver.

Each penetrating member 802 may be contained in a molded cavity 806 inthe cartridge 800 with the penetrating member's sharpened end facingradially outward and may be in the same plane as that of the cartridge.Although not limited in this manner, the ends of the protective cavities806 may be divided into individual fingers (such as one for each cavity)on the outer periphery of the disc. The particular shape of each cavity806 may be designed to suit the size or shape of the penetrating membertherein or the amount of space desired for placement of the analytesensors 808. For example and not limitation, the cavity 806 may have aV-shaped cross-section, a U-shaped cross-section, C-shapedcross-section, a multi-level cross section or the other cross-sections.The opening 810 through which a penetrating member 802 may exit topenetrate tissue may also have a variety of shapes, such as but notlimited to, a circular opening, a square or rectangular opening, aU-shaped opening, a narrow opening that only allows the penetratingmember to pass, an opening with more clearance on the sides, a slit, aconfiguration as shown in FIG. 75, or the other shapes.

After actuation, the penetrating member 802 is returned into thecartridge and may be held within the cartridge 800 in a manner so thatit is not able to be used again. By way of example and not limitation, aused penetrating member may be returned into the cartridge and held bythe launcher in position until the next lancing event. At the time ofthe next lancing, the launcher may disengage the used penetrating memberwith the cartridge 800 turned or indexed to the next clean penetratingmember such that the cavity holding the used penetrating member isposition so that it is not accessible to the user (i.e. turn away from apenetrating member exit opening). In some embodiments, the tip of a usedpenetrating member may be driven into a protective stop that hold thepenetrating member in place after use. The cartridge 800 is replaceablewith a new cartridge 800 once all the penetrating members have been usedor at such other time or condition as deemed desirable by the user.

Referring still to FIG. 73, the cartridge 800 may provide sterileenvironments for penetrating members via seals, foils, covers,polymeric, or similar materials used to seal the cavities and provideenclosed areas for the penetrating members to rest in. In the presentembodiment, a foil or seal layer 820 is applied to one surface of thecartridge 800. The seal layer 820 may be made of a variety of materialssuch as a metallic foil or other seal materials and may be of a tensilestrength and other quality that may provide a sealed, sterileenvironment until the seal layer 820 is penetrate by a suitable orpenetrating device providing a preselected or selected amount of forceto open the sealed, sterile environment. Each cavity 806 may beindividually sealed with a layer 820 in a manner such that the openingof one cavity does not interfere with the sterility in an adjacent orother cavity in the cartridge 800. As seen in the embodiment of FIG. 73,the seal layer 820 may be a planar material that is adhered to a topsurface of the cartridge 800.

Depending on the orientation of the cartridge 800 in the penetratingmember driver apparatus, the seal layer 820 may be on the top surface,side surface, bottom surface, or other positioned surface. For ease ofillustration and discussion of the embodiment of FIG. 73, the layer 820is placed on a top surface of the cartridge 800. The cavities 806holding the penetrating members 802 are sealed on by the foil layer 820and thus create the sterile environments for the penetrating members.The foil layer 820 may seal a plurality of cavities 806 or only a selectnumber of cavities as desired.

In a still further feature of FIG. 73, the cartridge 800 may optionallyinclude a plurality of analyte sensors 808 on a substrate 822 which maybe attached to a bottom surface of the cartridge 800. The substrate maybe made of a material such as, but not limited to, a polymer, a foil, orother material suitable for attaching to a cartridge and holding thesensors 808. As seen in FIG. 73, the substrate 822 may hold a pluralityof sensors, such as but not limited to, about 10-50, 50-100, or othercombinations of sensors. This facilitates the assembly and integrationof sensors 808 with cartridge 800. These sensors 808 may enable anintegrated body fluid sampling system where the penetrating members 802create a wound tract in a target tissue, which expresses body fluid thatflows into the cartridge for analyte detection by at least one of thesensors 808. The substrate 822 may contain any number of analyte sensors808 suitable for detecting analytes in cartridge having a plurality ofcavities 806. In one embodiment, many analyte sensors 808 may be printedonto a single substrate 822 which is then adhered to the cartridge tofacilitate manufacturing and simplify assembly. The sensors 808 may beelectrochemical in nature. The sensors 808 may further contain enzymes,dyes, or other detectors which react when exposed to the desiredanalyte. Additionally, the sensors 808 may comprise of clear opticalwindows that allow light to pass into the body fluid for analyteanalysis. The number, location, and type of sensor 808 may be varied asdesired, based in part on the design of the cartridge, number ofanalytes to be measured, the need for sensor calibration, and thesensitivity of the sensors. If the cartridge 800 uses a sensorarrangement where the sensors are on a substrate attached to the bottomof the cartridge, there may be through holes (as shown in FIG. 76),wicking elements, capillary tube or other devices on the cartridge 800to allow body fluid to flow from the cartridge to the sensors 808 foranalysis. In other configurations, the sensors 808 may be printed,formed, or otherwise located directly in the cavities housing thepenetrating members 802 or areas on the cartridge surface that receiveblood after lancing.

The use of the seal layer 820 and substrate or sensor layer 822 mayfacilitate the manufacture of these cartridges 10. For example, a singleseal layer 820 may be adhered, attached, or otherwise coupled to thecartridge 800 as indicated by arrows 824 to seal many of the cavities806 at one time. A sheet 822 of sensors may also be adhered, attached,or otherwise coupled to the cartridge 800 as indicated by arrows 825 toprovide many sensors on the cartridge at one time. During manufacturingof one embodiment of the present invention, the cartridge 800 may beloaded with penetrating members 802, sealed with layer 820 and atemporary layer (not shown) on the bottom where substrate 822 wouldlater go, to provide a sealed environment for the penetrating members.This assembly with the temporary bottom layer is then taken to besterilized. After sterilization, the assembly is taken to a clean roomwhere the temporary bottom layer is removed and the substrate 822 withsensors is coupled to the cartridge as shown in FIG. 73. This processallows for the sterile assembly of the cartridge with the penetratingmembers 802 using processes and/or temperatures that may degrade theaccuracy or functionality of the sensors on substrate 822.

In some embodiments, more than one seal layer 820 may be used to sealthe cavities 806. As examples of some embodiments, multiple layers maybe placed over each cavity 806, half or some selected portion of thecavities may be sealed with one layer with the other half or selectedportion of the cavities sealed with another sheet or layer, differentshaped cavities may use different seal layer, or the like. The seallayer 820 may have different physical properties, such as those coveringthe penetrating members 802 near the end of the cartridge may have adifferent color such as red to indicate to the user (if visuallyinspectable) that the user is down to say 10, 5, or other number ofpenetrating members before the cartridge should be changed out.

Referring now to FIGS. 74 and 75, one embodiment of the microfluidicsused with the sensors 808 in cartridge 800 will now be described. Forease of illustration, the shape of cavity 806 has been simplified into asimple wedge shape. It should be understood that more sophisticatedconfigurations such as that shown in FIG. 73 may be used. FIG. 74 showsa channel 826 that assists in drawing body fluid towards the sensors808. In the present embodiment, two sensors 808 are shown in the cavity806. This is purely for illustrative purposes as the cavity 806 may haveonly one sensor or any other number of sensors as desired. Body fluidentering cavity 806, while filling part of the cavity, will also bedrawn by capillary action through the groove 826 towards the sensors808.

FIG. 75 shows a perspective view of a cutout of the cavity 806. Thepenetrating member 802 (shown in phantom) is housed in the cavity 806and may extend outward through a penetrating member exit opening 830 asindicated by arrow 832. The position of the tip of penetrating member802 may vary, such as being near the penetrating member exit port orspaced apart from the exit. The location of the tip relative to thesensor 808 may also be varied, such as being spaced apart or away fromthe sensor or collocated or in the immediate vicinity of the sensor.Fluid may then enter the cavity 806 and directed by channel 826. Thechannel 826 as shown in FIG. 75 is a groove that is open on top. Thechannel 826 may be entirely a groove with an open top or it may have aportion that is has a sealed top forming a lumen, or still further, thegroove may be closed except for an opening near the penetrating memberexit opening 830. It should be understood that capillary action can beachieved using a groove having one surface uncovered. In someembodiments, the sensor 808 is positioned close to the penetratingmember exit opening 830 so that the sensor 808 may not need a capillarygroove or channel to draw body fluid, such as in FIG. 78.

As seen in FIGS. 75 and 76, the cavity 806 may include the substrate 822coupled to its bottom surface containing the sensors 808. With thesensors 808 located on the underside of the cartridge 800 as seen inFIG. 76, the cartridge 800 may include at least one through hole 834 toprovide a passage for body fluid to pass from the cavity 806 to thesensor 808. The size, location, shape, and other features of the throughhole 834 may be varied based on the cavity 806 and number of sensors 808to be provided. In other embodiments, wicking elements or the like maybe used to draw body fluid from the groove 826 to down to the sensor 808via the through hole or holes 834.

Referring now to FIG. 77, a variety of groove and sensor configurationsare shown on a single cartridge. These configurations are shown only forillustrative purposes and a single cartridge may not incorporate each ofthese configurations. It should be understood, however, that sensorconfiguration could be customized for each cavity, such as but notlimited to, using a different number and location of sensors dependinglancing variables associated with that cavity, such as the time of dayof the lancing event, the type of analyte to be measured, the test siteto be lanced, or other lancing parameter.

FIG. 77 shows a penetrating member 802 in a cavity 838 with threesensors 808 in the cavity. For ease of illustration, the penetratingmember 802 is omitted from the remaining cavities so that the sensorconfigurations can be more easily seen. Cavity 840 has a channel 826with two sensors 808. Cavity 842 has a channel 844 coupled to a singlesensor 808: Cavities 846 and 848 have one and two sensors 808,respectively. The sensors 808 in those cavities may be located directlyat the penetrating member exit from the cartridge or substantially atthe penetrating member exit. Other sensor configurations are alsopossible, such as but not limited to, placing one or more sensors on aside wall of the cavity, placing the sensors in particular arrays (forexample, a linear array, triangular array, square array, etc . . . ) onthe side wall or bottom surface, using mixed types of sensors (forexample, electrochemical and optical, or some other combination), ormixed positioning of sensors (for example, at least one sensor on thesubstrate below the cartridge and at least one sensor in the cavity).

FIG. 78 shows an embodiment of cartridge 800 where the sensor 850 islocated near the distal end of cavity 806. The sensor 850 may be formed,deposited, or otherwise attached there to the cartridge 800. In anotherembodiment, the sensor 850 may be a well or indentation having a bottomwith sufficient transparency to allow an optical sensor to detectanalytes in fluid deposited in the well or indentation. The well orindentation may also include some analyte reagent that reacts(fluoresces, changes colors, or presents other detectable qualities)when body fluid is placed in the well. In a still further embodiment,sensor 850 may be replaced with a through hole that allow fluid to passthere through. A sensor 808 on a substrate 822 may be attached to theunderside of the cartridge 800, accessing fluid passing from the cavity806 down to the sensor 808.

As mentioned above, the sensors 808 may also be placed right at theimmediate vicinity or slightly setback from the module opening receivingblood so that low blood volumes will still reach the sensor. The sensors808 may be used with low volumes such as less than about 1 microliter ofsample, preferably less than about 0.6 microliter, more preferably lessthan about 0.3 microliter, and most preferably less than about 0.1microliter of sample. Sensors 808 may also be directly printed or formedon the bottom of the penetrating member cartridge 800. In oneembodiment, a multiplicity of miniaturized sensor fields may be placedon the floor of the radial cavity or on the microfluidic module to allowmany tests on a single analyte form a single drop of blood to improveaccuracy and precision of measurement. Although not limited in thismanner, additional sensor fields or regions may also be included forcalibration or other purposes.

Referring now to FIGS. 79-84, further embodiments of the cartridge 800will now be described. FIG. 79 shows a cartridge 860 having ahalf-circular shape. FIG. 80 shows a cartridge 862 in the shape of apartial curve. FIG. 80 also shows that the cartridges 862 may be stackedin various configurations such as vertically, horizontally, or in otherorientations. FIG. 81 shows a cartridge 864 having a substantiallystraight, linear configuration. FIG. 82 shows a plurality of cartridges864 arranged to extend radially outward from a center 866. Eachcartridge may be on a slide (not shown for simplicity) that allows thecartridge 864 to slide radially outward to be aligned with a penetratingmember launcher. After use, the cartridge 864 is slide back towards thecenter 866 and the entire assembly is rotated as indicated by arrow 868to bring a new cartridge 864 into position for use with a penetratingmember driver. FIG. 83 shows a still further embodiment where aplurality of cartridges 800 may be stacked for use with a penetratingmember driver (see FIG. 85). The driver may be moved to align itselfwith each cartridge 800 or the cartridges may be moved to alightthemselves with the driver. FIG. 84 shows a still further embodimentwhere a plurality of cartridge 864 are coupled together with a flexiblesupport to define an array. A roller 870 may be used to move thecartridges 864 into position to be actuated by the penetrating memberdriver 872.

Referring now to FIG. 85, one embodiment of an apparatus 880 using aradial cartridge 800 with a penetrating member driver 882 is shown. Acontoured surface 884 is located near a penetrating member exit port886, allowing for a patient to place their finger in position forlancing. Although not shown, the apparatus 880 may include a humanreadable or other type of visual display to relay status to the user.The display may also show measured analyte levels or other measurementor feedback to the user without the need to plug apparatus 880 or aseparate test strip into a separate analyte reader device. The apparatus880 may include a processor or other logic for actuating the penetratingmember or for measuring the analyte levels. The cartridge 800 may beloaded into the apparatus 880 by opening a top housing of the apparatuswhich may be hinged or removably coupled to a bottom housing. Thecartridge 800 may also drawn into the apparatus 880 using a loadingmechanism similar in spirit to that found on a compact disc player orthe like. In such an embodiment, the apparatus may have a slot (similarto a CD player in an automobile) that allows for the insertion of thecartridge 800 into the apparatus 880 which is then automatically loadedinto position or otherwise seated in the apparatus for operationtherein. The loading mechanism may be mechanically powered orelectrically powered. In some embodiments, the loading mechanism may usea loading tray in addition to the slot. The slot may be placed higher onthe housing so that the cartridge 800 will have enough clearance to beloaded into the device and then dropped down over the penetrating memberdriver 882. The cartridge 800 may have an indicator mark or indexingdevice that allows the cartridge to be properly aligned by the loadingmechanism or an aligning mechanism once the cartridge 800 is placed intothe apparatus 880. The cartridge 800 may rest on a radial platform thatrotates about the penetrating member driver 882, thus providing a methodfor advancing the cartridge to bring unused penetrating members toengagement with the penetrating member driver. The cartridge 800 on itsunderside or other surface, may shaped or contoured such as withnotches, grooves, tractor holes, optical markers, or the like tofacilitate handling and/or indexing of the cartridge. These shapes orsurfaces may also be varied so as to indicate that the cartridge isalmost out of unused penetrating members, that there are only fivepenetrating members left, or some other cartridge status indicator asdesired.

A suitable method and apparatus for loading penetrating members has beendescribed previously in commonly assigned, copending U.S. patentapplications, and are included here by reference for all purposes.Suitable devices for engaging the penetrating members and for removingprotective materials associated with the penetrating member cavity aredescribed in commonly assigned, copending U.S. patent applications, andare included here by reference for all purposes. For example in theembodiment of FIG. 78, the foil or seal layer 820 may cover the cavityby extending across the cavity along a top surface 890 and down alongthe angled surface 892 to provide a sealed, sterile environment for thepenetrating member and sensors therein. A piercing element described inU.S. patent applications has a piercing element and then a shapedportion behind the element which pushes the foil to the sides of thecavity or other position so that the penetrating member 802 may beactuated and body fluid may flow into the cavity.

Referring now to FIG. 86, a still further embodiment of a lancing systemaccording to the present invention will be described. A radial cartridge500 may be incorporated for use with a penetrating member driver 882. Apenetrating member may be driven outward as indicated by arrow 894. Aplurality of analyte sensors are presented on a roll 895 that is laidout near a penetrating member exit. The roll 895 may be advanced asindicated by arrow 896 so that used analyte sensors are moved away fromthe active site. The roll 895 may also be replaced by a disc holding aplurality of sensors, wherein the sensor disc (not shown) is oriented ina plane substantially orthogonal to the plane of cartridge 500. Thesensor disc may also be at other angles not parallel to the plane ofcartridge 500 so as to be able to rotate and present new, unused sensorin sequence with new unused penetrating members of cartridge 500.

Referring now to FIG. 87A, the cartridge 500 provides a high densitypackaging system for a lancing system. This form factor allows a patientto load a large number penetrating members through a single cartridgewhile maintaining a substantially handheld device. Of course such acartridge 500 may also be used in non-handheld devices. The presentcartridge 500 provide a high test density per volume of the disposable.For embodiments of a cartridge that includes sensors in addition topenetrating members such as cartridge 800, the density may also bemeasured in terms of density of sensors and penetrating members in adisposable. In other embodiments, the density may also be expressed interms of sensors per disposable. For example, by taking the physicalvolume of one embodiment or the total envelope, this number can bedivided by the number of penetrating members or number of tests. Thisresult is the volume per penetrating member or per test in a cassettedfashion. For example, in one embodiment of the present invention, thetotal volume of the cartridge 500 is determined to be 4.53 cubiccentimeters. In this one embodiment, the cartridge 500 holds 50penetrating members. Dividing the volume by 50, the volume per test isarrived at 0.090 cubic centimeters. Conventional test devices such asdrum is in the range of 0.720 or 0.670 cubic centimeters and that issimply the volume to hold a plurality of test strips. This does notinclude penetrating members as does the present embodiment 800. Thus,the present embodiment is at a substantially higher density. Even aslightly lower density device having penetrating members and sensors inthe 0.500 cubic centimeter range would be a vast improvement over knowndevices since the numbers listed above for known devices does notinclude penetrating members, only packaging per test strip.

Referring now to FIG. 87B, a still further embodiment of a cartridgeaccording to the present invention will now be described. FIG. 87B showsa cross-section of a conical shaped cartridge with the penetratingmember being oriented in one embodiment to move radially outward asindicated by arrow 897. In another embodiment, the penetrating membermay be oriented to move radially inward as indicated by arrow 895. Thegripper may be positioned to engage the penetrating member from an innersurface or an outer surface of the cartridge.

Referring now to FIG. 88, nanowires may also be used to create lowvolume sensors used with the cartridge 800. Further details of ananowire device is described in commonly assigned, copending U.S.Provisional Patent Application Ser. No. 60/433,286 filed Dec. 13, 2002,fully incorporated herein by reference for all purposes. These nanowiresensors 898 may be incorporated into the cavity 806 housing thepenetrating member 802. They may be placed on the floor or bottomsurface of the cavity 806, on the wall, on the top surface, or anycombinations of some or all of these possibilities. The sensors 898 maybe designed to have different sensitivity ranges so as to enhance theoverall sensitivity of an array of such sensors. Methods to achieve thismay include, but are not limited to, using nanowires of varying sizes,varying the number of nanowires, or varying the amount of glucoseoxidase or other glucose detection material on the nanowires. Thesenanowire sensors may be designed to use low volumes of body fluid foreach sample, due to their size. In some embodiments, each of the sensorsare accurate using volumes of body fluid sample less than about 500nanoliters. In some embodiments, each of the sensors are accurate usingvolumes of body fluid sample less than about 300 nanoliters. In stillother embodiments, each sensor is accurate with less than about 50nanoliters, less than about 30 nanoliters, less than about 10nanoliters, less than about 5 nanoliters, and less than about 1nanoliters of body fluid sample. In some embodiments, the combined arrayof sensors uses less than 300 nanoliters of body fluid to arrive at ananalyte measurement.

Referring now to FIG. 89, a still further embodiment of the presentinvention will be described. FIG. 89 shows one embodiment of an opticalillumination system 910 for use with optical analyte sensors (FIG. 91)that may be in contact with a body fluid sample. The overall system mayinclude a plurality of analyte sensors which provide some opticalindicator, a light source 912 for providing light to shine on thesensors, at least one light detector 914, and a processor (not shown).The sensor or sensors are exposed to a sample of the fluid of unknowncomposition. A plurality of sensors may be arranged into an array ofsensors exposed to one fluid sample, each group targeting a specificanalyte and may contain an analyte-specific chemical that interacts morespecifically with one analyte than with some other analytes to beanalyzed. Each sensor may also have different sensitivity ranges so asto maximize overall sensitivity of an array of such sensors. The lightsource 912 shines light on at least one sensor to cause lightinteraction. The differences in the sensors may lead to differences inthe light interaction. The light detector detects the light interactionby the sensors. The processor analyzes the light interaction by thesensors to take into account interference in light interaction among theanalytes, thereby determining the concentration of the desired analytein the fluid.

Referring still to the embodiment of FIG. 89, the light source 912 maybe but is not limited to an LED. An alternative LED 915 may also be usedwith the present invention. Light, illumination, or excitation energyfrom LED 912 travels along a path through a pinhole 916, a filter 917,and a lens 918. The light then comes into contact with a beamsplitter919 such as a dichroic mirror or other device useful for beamsplitting.The light is then directed towards lens 920 as indicated by arrow 921.The lens 920 focuses light onto the sensor (FIG. 91). This excitationenergy may cause a detectable optical indicator from the sensor. By wayof example and not limitation, fluorescence energy may be reflected bayup the lens 920. This energy passes through the beamsplitter 919 and tolens 922 which is then received by detector 914 as indicated by arrow923. The detector 914 measures the energy and this information is passedon to the processor (not shown) to determine analyte levels. Theillumination system 910 may also include cells 924 on the disc surface.In this specific embodiment, a penetrating member 925 drive by a forcegenerator 926 such as but not limited to a solenoid may be used toobtain the fluid sample. A detent 927 may also be included with thedevice along with other bare lancets or penetrating members 928.

Referring now to FIG. 90, another embodiment of the illumination system910 is shown for use with a cartridge 929. Cartridge 929 is similar tocartridge 800. Cartridge 929 is a single cartridge having a plurality ofpenetrating members and a plurality of optical sensors (not shown). Thecartridge 929 further includes a plurality of optically transparentportions 930 which may be but is not limited to windows or the like forthe light from LED 912 to shine into a cavity of the cartridge 929. Inone embodiment, each cavity of the cartridge 929 may include at leastone transparent portion 930. This allows the light to generate energythat may be read by sensor 914. The cartridge 929 may be used a driver882 to actuate penetrating members and the cartridge 929 may rotate asindicated by arrow 931.

Referring now to FIG. 91, a cross-section of a similar embodiment of theillumination system is shown. This system 932 has source 912 with a lens933 having an excitation filter 934. This excitation filter 934, in oneembodiment, only allows excitation energy to pass. This filter 934allows the excitation energy to pass to dichroic mirror 935, but doesnot let it return to source 912. Excitation energy is reflected down asindicated by arrow 936. Lens 937 focuses the energy to optical analytesensor 938. Fluorescence energy 939 passes through the dichroic mirror935 and towards a fluorescent filter 940. In one embodiment, thefluorescent filter 940 only allows fluorescent energy to pass through tolens 941. Thus, the detector 914 only receives fluorescent energy fromthe sensor 938. It should be understood of course, that the filter maybe changed to allow the type of energy being generated by sensor 938 topass. In some embodiments, no filter may be used. The dichroic mirror935 may be a Bk7 substrate, 63×40×8 mm. The filters may also be a Bk7substrate about 40 mm in diameter and about 6 mm thick. The lens 933,937, and 941 may be achormat:bfl=53.6, working aperture 38 mm.

Referring now to FIG. 92, a still further embodiment of an illuminationsystem 942 will be described. This system does not use a beamsplitter ordichroic mirror. Instead, both the source or LED 912 and detector 914have direct line of sight to the optical analyte sensor 938. In thisembodiment, multiple elements are combined into a single housing. Forexample, lens 943, lens 944, and filter 945 are combined while lens 946,lens 947, and filter 948 are also combined.

Referring now to FIG. 93, a cross-section of a system similar to that ofFIG. 89 is shown in a housing 950. LED 912 sends light to mirror 919 toa light path 951 to cells 924 on a surface of the disc. A finger access952 allows a sample to be obtained and flow along a fluid pathway 953 tobe analyzed. A processor 954 may be coupled to detector 914 to analyzethe results.

Referring now to FIG. 94, a cross-section of a system similar to that ofFIG. 90 will be further described. This shows a cartridge 929 used witha driver 882. This allows for a radial design where the penetratingmembers extend radially outward as indicated by arrow 955. The driver882 may have a coupler portion that reciprocates as indicated by arrow956. FIGS. 95 and 96 provide further views of a system similar to thatof FIG. 89. The embodiment of FIGS. 95 and 96 may include additionallenses or filters as may be useful to refine energy detection.

While the invention has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, with any of the above embodiments, the location of thepenetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). With any of the above embodiments, thepenetrating members may be a bare penetrating member during launch. Withany of the above embodiments, the penetrating members may be barepenetrating members prior to launch as this may allow for significantlytighter densities of penetrating members. In some embodiments, thepenetrating members may be bent, curved, textured, shaped, or otherwisetreated at a proximal end or area to facilitate handling by an actuator.The penetrating member may be configured to have a notch or groove tofacilitate coupling to a gripper. The notch or groove may be formedalong an elongate portion of the penetrating member. With any of theabove embodiments, the cavity may be on the bottom or the top of thecartridge, with the gripper on the other side. In some embodiments,sensors may be printed on the top, bottom, or side of the cavities. Thefront end of the cartridge maybe in contact with a user during lancing.The same driver may be used for advancing and retraction of thepenetrating member. The penetrating member may have a diameters andlength suitable for obtaining the blood volumes described herein. Thepenetrating member driver may also be in substantially the same plane asthe cartridge. The driver may use a through hole or other opening toengage a proximal end of a penetrating member to actuate the penetratingmember along a path into and out of the tissue.

Any of the features described in this application or any referencedisclosed herein may be adapted for use with any embodiment of thepresent invention. For example, the devices of the present invention mayalso be combined for use with injection penetrating members or needlesas described in commonly assigned, copending U.S. patent applicationSer. No. 10/127,395 filed Apr. 19, 2002. A sensor to detect the presenceof foil may also be included in the lancing apparatus. For example, if acavity has been used before, the foil or sterility barrier will bepunched. The sensor can detect if the cavity is fresh or not based onthe status of the barrier. It should be understood that in optionalembodiments, the sterility barrier may be designed to pierce a sterilitybarrier of thickness that does not dull a tip of the penetrating member.The lancing apparatus may also use improved drive mechanisms. Forexample, a solenoid force generator may be improved to try to increasethe amount of force the solenoid can generate for a given current. Asolenoid for use with the present invention may have five coils and inthe present embodiment the slug is roughly the size of two coils. Onechange is to increase the thickness of the outer metal shell or windingssurround the coils. By increasing the thickness, the flux will also beincreased. The slug may be split; two smaller slugs may also be used andoffset by ½ of a coil pitch. This allows more slugs to be approaching acoil where it could be accelerated. This creates more events where aslug is approaching a coil, creating a more efficient system.

In another optional alternative embodiment, a gripper in the inner endof the protective cavity may hold the penetrating member during shipmentand after use, eliminating the feature of using the foil, protectiveend, or other part to retain the used penetrating member. Some otheradvantages of the disclosed embodiments and features of additionalembodiments include; same mechanism for transferring the usedpenetrating members to a storage area; a high number of penetratingmembers such as 25, 50, 75, 100, 500, or more penetrating members may beput on a disk or cartridge; molded body about a lancet becomesunnecessary; manufacturing of multiple penetrating member devices issimplified through the use of cartridges; handling is possible of barerods metal wires, without any additional structural features, to actuatethem into tissue; maintaining extreme (better than 50 micron—lateral—andbetter than 20 micron vertical) precision in guiding; and storage systemfor new and used penetrating members, with individual cavities/slots isprovided. The housing of the lancing device may also be sized to beergonomically pleasing. In one embodiment, the device has a width ofabout 56 mm, a length of about 105 mm and a thickness of about 15 mm.Additionally, some embodiments of the present invention may be used withnon-electrical force generators or drive mechanism. For example, thepunch device and methods for releasing the penetrating members fromsterile enclosures could be adapted for use with spring based launchers.The gripper using a frictional coupling may also be adapted for use withother drive technologies.

Still further optional features may be included with the presentinvention. For example, with any of the above embodiments, the locationof the penetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). The penetrating members may be a barepenetrating member during launch. The same driver may be used foradvancing and retraction of the penetrating member. Different sensorsdetecting different ranges of glucose concentration, different analytes,or the like may be combined for use with each penetrating member.Non-potentiometric measurement techniques may also be used for analytedetection. For example, direct electron transfer of glucose oxidasemolecules adsorbed onto carbon nanotube powder microelectrode may beused to measure glucose levels. In all methods, nanoscopic wire growthcan be carried out via chemical vapor deposition (CVD). In all of theembodiments of the invention, preferred nanoscopic wires may benanotubes. Any method useful for depositing a glucose oxidase or otheranalyte detection material on a nanowire or nanotube may be used withthe present invention. This application cross-references commonlyassigned copending U.S. patent applications Ser. No. 10/323,623 filedDec. 18, 2002; commonly assigned copending U.S. patent applications Ser.No. 10/323,624 filed Dec. 18, 2002; and commonly assigned copending U.S.patent applications Ser. No. 10/324,053 filed Dec. 18, 2002. Allapplications listed above are fully incorporated herein by reference forall purposes. Expected variations or differences in the results arecontemplated in accordance with the objects and practices of the presentinvention. It is intended, therefore, that the invention be defined bythe scope of the claims which follow and that such claims be interpretedas broadly as is reasonable.

1. A lancing system, comprising: a disposable having a plurality ofcavities; and a plurality of bare penetrating members with no raisedformations or molded parts at least partially contained in said cavitiesof the single disposable wherein the bare penetrating members areslidably movable to extend outward from lateral openings on saiddisposable to penetrate tissue; and a bare penetrating member gripperthat grips each of the bare penetrating members in order to couple thepenetrating member to and driven by a penetrating member driver during alaunch of the penetrating member, wherein the gripper creates africtional grip with the bare penetrating member.
 2. The system of claim1, wherein the bare penetrating member gripper is not positively coupledto the disposable.
 3. The system of claim 1, wherein the gripper has legportions spread open elastically to create a frictional grip with thebare penetrating member.
 4. The system of claim 1, wherein the gripperhas a tuning fork shaped configuration.
 5. The system of claim 1,wherein the gripper moves vertically relative to the bare penetratingmember to engage an elongate portion of the penetrating member.
 6. Thesystem of claim 1, further comprising: a gripper block for coupling thegripper to the penetrating member driver.